Clinical Research Directory

TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)

The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS) works to help people recover faster after laparoscopic surgery for stomach cancer. TEAS is a treatment that uses small electrical pulses through sticky pads on the skin. It does not use needles. The main questions it aims to answer are: Does TEAS help people pass gas (a sign that the digestive system is waking up) sooner after surgery? Does TEAS help lower pain after surgery? Does TEAS reduce the need for extra pain medication after surgery? Researchers will compare three groups to see if TEAS works better when given before, during, and after surgery compared with only after surgery. Group 1 receives TEAS before, during, and after surgery. Group 2 receives a sham (inactive) treatment before and during surgery, and real TEAS after surgery. Group 3 receives sham treatment at all time points. All participants will receive the same standard pain relief and recovery care after surgery. Participants will: Be randomly assigned (like flipping a coin) to one of the three groups Receive TEAS or sham treatment for 30 minutes before surgery, during surgery, and for 30 minutes each day on the first 3 days after surgery Rate their pain on a 0-10 scale at 6, 12, 24, 48, and 72 hours after surgery Complete quality-of-life questionnaires before surgery, on day 4 after surgery, and 30 days after surgery Have a follow-up visit or phone call 30 days after leaving the hospital This study includes 300 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 13 hospitals in Shandong Province, China.

TEAS for Gastrectomy Recovery

The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS) works to help people recover faster after laparoscopic surgery for stomach cancer. TEAS is a treatment that uses small electrical pulses through sticky pads on the skin. It does not use needles. The main questions it aims to answer are: Does TEAS help people pass gas (a sign that the digestive system is waking up) sooner after surgery? Does TEAS help lower pain after surgery? Does TEAS reduce the need for extra pain medication after surgery? Researchers will compare two groups to see if TEAS works better than a sham (inactive) treatment. Group 1 (TA group) receives real TEAS after surgery. Group 2 (SA group) receives a sham treatment at the same time points. All participants will receive the same standard pain relief and recovery care after surgery. Participants will: Be randomly assigned (like flipping a coin) to one of the two groups. Receive TEAS or sham treatment for 30 minutes starting 2 hours after waking from anesthesia, and then once daily each morning on the first 3 days after surgery. Rate their pain on a 0-10 scale at 6, 12, 24, 48, and 72 hours after surgery. Complete quality-of-life and fatigue questionnaires before surgery, on day 4 after surgery, and 30 days after surgery. Have a follow-up visit or phone call 30 days after leaving the hospital. This study includes 104 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 8 hospitals in Shandong Province, China.

SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors

This is a phase 1, multicenter, open-label, single-arm study evaluating SND002 Cell Injection in participants with advanced malignant solid tumors that have progressed after standard treatment or for whom no standard treatment is available. SND002 Cell Injection is an investigational product made from a participant's own immune cells (T cells). These cells are collected from a lymph node that drains the tumor, expanded in a laboratory, and then given back to the same participant by intravenous infusion. Because the cells come from the participant, the approach is intended to help the participant's immune system recognize and attack the tumor. The study has two parts. In Part A, small groups of participants receive increasing numbers of cells to identify the dose range that is safest and best tolerated. In Part B, additional participants with colorectal cancer, gastric cancer, or other solid tumors receive the dose range selected in Part A, to learn more about antitumor activity. Before the infusion, participants receive a short course of chemotherapy to prepare the body for the cells. After the infusion, participants receive interleukin-2 injections for several days and are monitored closely. Safety is assessed for 28 days after the infusion, and participants are then followed for up to 1 year to assess tumor response and survival. The main questions are (1) what side effects occur, how severe they are, and what dose range is recommended for further study, and (2) in the expansion part, how many participants experience a reduction in tumor size. Approximately 69 to 78 participants will be enrolled at multiple hospitals in China. Follow-up continues for up to 1 year after the infusion.

Hereditary Gastric Cancer Syndromes: An Integrated Genomic and Clinicopathologic Study of the Predisposition to Gastric Cancer

Background: Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child. Researchers want to gather data about hereditary gastric cancers. They want to learn about changes these cause in the body and about the genes involved. Objective: -To gather data about hereditary gastric cancer. Eligibility: * People at least 2 years old with personal or family history with a hereditary gastric cancer. * People at least 2 years old with gene changes that lead to such cancer or a lesion that may be hereditary. Design: * Participants will be screened in a separate protocol. * Participants will have: * Physical exam * Medical history * Blood tests * Scans * Photos of skin lesions and other findings * Gynecology consultation for women * Cheek swab (some participants) * For some participants, their relatives will be asked to join the study. * Some participants will be asked to allow the study to get stored tissue samples for relatives who have died. * Some samples will be sent to outside labs. All personal data will be protected. Samples will be destroyed when the study ends. * Participants will get the results of genetic testing. * Participants who cannot come to the NIH clinic may just give a cheek swab and have genetic testing done. * Some participants will be contacted for more testing.

Lymph Node Metastasis Pattern After Neoadjuvant Chemoimmunotherapy in LAGC

The purpose of this observational study is to learn how stomach cancer that has spread to nearby lymph nodes responds to standard chemotherapy combined with immunotherapy given before surgery. In people with locally advanced gastric cancer, this pre-surgery treatment can shrink the tumor and clear cancer cells from some lymph nodes. However, it is not clear which groups of lymph nodes around the stomach still contain cancer cells after treatment. The study will also examine whether dense scarring (fibrosis) around the tumor is linked to a lower chance of cancer remaining in the lymph nodes. This information may help doctors in the future decide whether some lymph node groups can be safely left in place during surgery for people with severe scarring. Participants in this study will receive standard pre-surgery treatment with SOX chemotherapy (S-1 plus oxaliplatin) and a PD-1 inhibitor for at least 2 cycles. After treatment, they will undergo standard gastrectomy with D2 lymph node dissection, which is the routine surgical removal of the main lymph node groups around the stomach. During surgery, the surgeon will record the degree of scarring and difficulty in separating the tissues. Lymph nodes will be collected and labeled by station so that each group can be examined separately. The study will then describe how often cancer is found in each lymph node station after treatment and explore whether scarring is related to cancer remaining in the nodes. The study will also track surgical outcomes and follow participants for up to 3 years to assess cancer recurrence and survival. Approximately 103 participants will be enrolled. The study is expected to run from January 2027 through December 2029. Each participant will be followed for about 3 years after surgery, with clinic visits every 3 months for the first 2 years and every 6 months in the third year. This study does not assign participants to different treatments; all participants receive standard care, and the study only observes and records the results.

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.

Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction

This is a multicenter, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG. The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are: Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. Participants will: Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Background: * Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. * Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. * The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. * Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. * In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: * All participants age greater than or equal to 2 years with malignant mesothelioma OR * All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin * Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: * Up to 1000 subjects will be enrolled. * Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. * Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. * Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Background: Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN. Objective: To test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma. Eligibility: People aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment. Design: Participants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN. Participants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. Participant s T cells will be modified in a lab to produce TNhYP218 CAR T cells. Participants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment. TNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days. After discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy. Long-term follow-up will continue another 10 years....

Conversion Therapy Plus Surgery and Radiotherapy for Retroperitoneal Nodal Metastases in Gastric Cancer

This is a randomized, controlled, multicenter phase II clinical trial evaluating the efficacy and safety of conversion therapy combined with radical gastrectomy and adjuvant radiotherapy targeting para-aortic (station 16) lymph nodes in patients with gastric adenocarcinoma and isolated station 16 nodal metastases. Eligible participants must have no evidence of peritoneal dissemination, visceral metastases, or non-regional lymphatic spread. Based on PD-L1 combined positive score (CPS), patients in the experimental arm will receive systemic therapy with SOX (S-1 plus oxaliplatin) with or without a PD-1 inhibitor, followed by D2 gastrectomy and postoperative adjuvant SOX chemotherapy, then intensity-modulated radiotherapy (IMRT) to the para-aortic region. The control arm will receive standard chemotherapy with CAPEOX or SOX, with or without immunotherapy, according to CPS status. The primary endpoint is progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. This study aims to explore whether the addition of locoregional treatment to systemic therapy improves long-term outcomes in this select patient population.

Pathological Response to Perioperative FLOT in Gastric Adenocarcinoma

Perioperative chemotherapy with the FLOT regimen (5-fluorouracil, leucovorin, oxaliplatin and docetaxel) is a standard treatment for resectable gastric and gastroesophageal junction adenocarcinoma. However, real-world studies have reported lower pathological complete response rates than the pivotal trials, and Colombian evidence is limited, coming mainly from surgical series focused on operative outcomes. This descriptive retrospective study will review the medical records of adults with stage I to III gastric or gastroesophageal junction adenocarcinoma who started perioperative FLOT at Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2021 and December 31, 2025 (approximately 90 patients). It will describe pathological response (tumor regression grade by the Mandard system and pathological complete response), grade 3-4 toxicity, dose modifications, treatment adherence and completion, recurrence and overall survival. The investigators will not assign or modify any treatment, and no hypothesis testing will be performed.

Maintenance Therapy in Metastatic Gastric Cancer: A Multicenter Retrospective Study in Colombia

Metastatic gastric cancer has a poor prognosis, and the cumulative toxicity of first-line platinum and fluoropyrimidine chemotherapy limits how long treatment can be continued. Maintenance therapy, in which patients whose disease is at least stable after induction chemotherapy continue on a less toxic regimen, is increasingly used, most often with fluoropyrimidines (capecitabine, 5-fluorouracil or S-1) and, in selected molecular subgroups, with immunotherapy or targeted therapy. Evidence on the outcomes of these strategies in Latin American patients is scarce. This multicenter retrospective study will review the medical records of adults with metastatic gastric cancer treated between 2013 and 2023 at four high-complexity cancer centers in Bogotá, Colombia, who received maintenance therapy after achieving at least stable disease with induction chemotherapy. The study will describe the demographic, clinical, pathological and molecular characteristics of these patients and estimate overall survival, progression-free survival, treatment response, toxicity and mortality. The investigators will not assign or modify any treatment.

HTL0039732 in Participants With Advanced Solid Tumours

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

Robotic vs Laparoscopic and Open Surgery for Abdominopelvic Cancers

Robotic surgery has become an increasingly common option for treating cancers in the abdomen and pelvis. However, whether robotic surgery leads to better cancer-related outcomes than laparoscopic (keyhole) surgery or open surgery is still uncertain. Results may differ across cancer types, and factors such as how complex the surgery is and how experienced the surgeon is may also influence the outcome. This retrospective cohort study examined adults who underwent curative-intent surgery for one of seven abdominopelvic cancers (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at a large tertiary hospital in Seoul, South Korea, between January 2012 and December 2021. Patients were classified into three groups according to the surgical approach they received: open, laparoscopic, or robotic surgery. The main outcome was 1-year disease-free survival, defined as the time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. Additional outcomes included 1-year mortality, overall mortality during follow-up, major postoperative complications, acute kidney injury, and length of hospital stay. To reduce differences between groups that might affect the comparison, the study used a statistical method called propensity score overlap weighting. Additional analyses adjusted for surgical complexity, surgeon experience including robotic learning curve, and pathological cancer stage to isolate the effect of the surgical platform itself. The purpose of this study was to evaluate whether the association between surgical approach and early oncologic and perioperative outcomes differed across the seven cancer types, and whether any observed advantage of the robotic platform remained after accounting for these factors.

A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer

English Translation (for ClinicalTrials.gov Patient-Friendly Summary): This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer). We are looking for participants whose cancer has progressed after one prior standard chemotherapy regimen and whose tumors test positive for the PD-L1 protein. This study is testing the effectiveness of a combination of three medications: 1. Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues. 2. Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply. 3. Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells. The primary goal of this study is to evaluate how well this three-drug combination works and to monitor its safety. Participants will receive the study drugs via intravenous infusion or oral tablets according to the protocol. Their progress will be tracked with CT scans and blood tests every three months. Regular follow-up visits will continue even after stopping treatment to monitor long-term outcomes. Who can participate? Participants must be adults diagnosed with advanced gastric cancer who have progressed after only one prior first-line standard therapy, have PD-L1-positive tumors, and have no severe heart, liver, or kidney disease. Pregnant or breastfeeding women cannot participate. Possible side effects Potential side effects may include nausea, vomiting, diarrhea, hand-foot swelling, low blood cell counts (which can increase infection risk), and fatigue. The research team will closely monitor all participants and provide prompt treatment for any side effects. Important note This study is still in the clinical trial phase. While it offers a potential new treatment option beyond standard care, there is no guarantee that the drugs will be effective for every participant. For more information, please contact the research team.

A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment

Many clinical trials evaluating cancer treatments require patients to undergo testing for specific molecular markers as part of eligibility screening, typically using immunohistochemistry or sequencing. Because relatively few patients may carry a required marker, trial investigators often test large numbers of patients to identify the few who may ultimately qualify for enrollment. Pathology laboratories routinely produce hematoxylin-and-eosin (H\&E) slides during cancer diagnosis. Pathology foundation models-large neural networks pretrained on millions of histology images-have shown promise in predicting molecular characteristics from these slides. Researchers can use these models to build classifiers that predict specific molecular markers and prioritize patients for confirmatory testing. This study evaluates FATHOM (Facilitating Accrual through Tumor Histology and Omics Matching), an autonomous research system powered by large multimodal models. Its agents read registered clinical trial records, identify molecular markers used as enrollment criteria, build prediction models using pathology foundation models, select the individual models or model combinations that best meet prespecified criteria, set their decision thresholds, and determine whether to deploy them. Together, a prediction model, its decision threshold, and the decision to deploy it constitute an AI prediction policy. Before FATHOM runs, the investigators preregister the clinical trial records that its agents may read, the cutoff date that defines which trial information they may use, the rules governing the agents, and the analysis plan. The system timestamps and locks each policy immediately after an agent produces it. The investigators then apply the policies to archived patient slides and compare their predictions with existing molecular marker results. The primary outcome is the proportion of prespecified evaluation scenarios in which an agent-generated policy, compared with universal molecular testing, either enriches the population selected for confirmatory testing with marker-positive patients or safely spares patients from confirmatory testing while meeting prespecified performance criteria. This study analyzes existing pathology images and clinical trial records only. It does not enroll or contact patients, influence patient care, or affect participation in any clinical trial.

Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy

This prospective, randomized, phase 4 clinical trial aims to evaluate the efficacy and safety of intravenous Maxigesic, a fixed-dose combination of acetaminophen and ibuprofen, for postoperative pain control in patients undergoing laparoscopic or robotic gastrectomy for gastric cancer. A total of 90 participants will be randomly assigned to receive either Maxigesic or intravenous acetaminophen. The primary objective is to compare postoperative pain control between the two groups using the sum of pain intensity differences over 72 hours (SPID72). Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesic use, antiemetic use, and safety outcomes.

Malignant Gastric Outlet Obstruction Study With Stomach Partitioning (GO-PART)

The goal of this clinical trial is to evaluate whether stomach-partitioning gastrojejunostomy (SPGJ) more effectively reduces postoperative delayed gastric emptying (DGE) compared to conventional gastrojejunostomy (CGJ) in patients with unresectable stage IV gastric cancer accompanied by malignant gastric outlet obstruction (MGOO). This multicenter randomized trial aims to establish a new surgical standard that enhances recovery and quality of life in advanced gastric cancer. The main questions are: 1. Does SPGJ significantly decrease DGE compared with CGJ? 2. Does SPGJ enable faster food tolerance, shorter hospital stay, and earlier chemotherapy? Researchers will compare two arms - SPGJ and CGJ - to determine differences in postoperative gastric emptying, hospital course, complications, and survival outcomes. Participants Eligible participants are adults aged 20-85 years with histologically proven unresectable gastric adenocarcinoma limited to the lower third of the stomach and endoscopic or radiologic evidence of obstruction. Patients with total bowel obstruction, middle-third tumor extension, emergency conditions, or severe malnutrition (albumin \< 2.5 g/L) are excluded. Interventions * CGJ arm: Standard laparoscopic gastrojejunostomy using a 60 mm stapler without partitioning. * SPGJ arm: Laparoscopic transverse gastric partitioning 5 cm proximal to the tumor with a 2 cm bridge at the lesser curvature, followed by stapled gastrojejunostomy. All operations follow standardized training videos and pretrial workshops to ensure consistency across 32 Korean university hospitals. Study Design This is a prospective, randomized controlled multicenter trial (KLASS 16). After intraoperative diagnostic laparoscopy confirms eligibility, participants are randomized by a secure web-based block system stratified by hospital. A total of 144 patients (72 per arm) will be enrolled, ensuring 90% statistical power based on expected DGE rates (CGJ 34.6% vs SPGJ 3.8%). Endpoints * Primary endpoint: Incidence of DGE within 30 days (ISGPS criteria). * Secondary endpoints: Day of oral tolerance (GOO score ≥ 2), hospital stay, Clavien-Dindo ≥ II complications, mechanical obstruction recurrence, 6 and 12 month overall survival, and quality of life. Data Collection and Analysis Data will include postoperative nutrition recovery, complication grades, and survival follow-up. Analyses will utilize Chi square or Fisher's exact test for DGE rates and Kaplan-Meier with log rank testing for survival. Logistic regression will identify DGE risk factors. Duration Total 3 years: 6 months preparation, 1 year enrollment, 1 year follow up, and 6 months for data analysis and reporting. Expected Outcomes SPGJ is expected to reduce DGE by \> 70%, shorten hospital stay by \~3 days, and enable earlier chemotherapy, thereby improving palliative care outcomes and overall patient quality of life. The KLASS 16 trial will provide the first multicenter, Level I evidence to determine whether SPGJ should replace CGJ as the standard palliative procedure for MGOO.

Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia

DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles. This prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging. The study also estimates positive and negative predictive values (PPV/NPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Participants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. This study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.

A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy

Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Acetaminophen is the most commonly used non-opioid analgesic in gastrectomy patients; adding ibuprofen as a fixed-dose combination has shown improved analgesia and opioid-sparing effects compared with acetaminophen alone in other surgical populations, but direct evidence in gastrectomy patients is limited. Objective: To evaluate whether scheduled administration of an acetaminophen-ibuprofen fixed-dose combination (Maxigesic® IV) is superior to acetaminophen alone for pain relief after radical gastrectomy, with exploratory assessment of cost-effectiveness and of differences in analgesic efficacy according to genetic polymorphisms. Hypothesis: When given on an identical scheduled regimen, the acetaminophen-ibuprofen fixed-dose combination produces significantly lower pain scores (NRS) over the first 48 postoperative hours than acetaminophen alone (superiority). Study plan: This is a phase IV, multicenter, double-blind, randomized controlled trial in which 160 gastric cancer patients scheduled for minimally invasive radical gastrectomy (80 per arm) are randomized 1:1 with stratification by institution. In both arms, the assigned drug is given as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery through 48 hours postoperatively. The primary endpoint is the between-group difference in the time-weighted average (TWA) of repeatedly measured resting and active NRS over 48 hours, analyzed using a mixed model for repeated measures (MMRM); secondary endpoints include opioid consumption (MME), the Quality of Recovery score (QoR-15K), the incidence of chronic postsurgical pain (CPSP), and in-hospital costs.