Clinical Research Directory

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive substance. Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine.

Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.

Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery

RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy and to see how well it works in treating liver metastases in patients with metastatic colorectal cancer.

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.

REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers

EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden

Patients with multiple colorectal liver metastases that progress on 1st line chemotherapy have a very dismal prognosis, and their options are few. Resections are regularly performed although this is only supported by anecdotal evidence for this patient group. We want to assess whether resections actually confer benefit as compared to 2nd line chemotherapy alone, in a randomized controlled trial.

HAI-Floxuridine, or Liver-Tx, Combined With 2nd Line Chemotherapy Versus 2nd Line Chemotherapy Alone for Patients With Colorectal Liver Metastases and Heavy Tumour Burden.

Patients with colorectal livermetasteses and heavy tumour burden and progression on 1st line chemotherapy have no other available treatment in Norway today other than 2nd line chemotherapy. The Investigators will randomize patients to HAI-floxuridine (FUDR), or liver-Tx, in addition to 2nd line chemotherapy versus 2nd line chemotherapy alone (Excalibur 1) or systemic chemotherapy with HAI/FUDR versus systemic chemotherapy alone (Excalibur 2). Primary endpoint is overall survival at 2yrs.

Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation

The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR

Aspirin in Colorectal Cancer Liver Metastases

The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose acetylsalicylic acid (ASA) can improve disease free survival in patients treated with resection for colorectal cancer liver metastases (CRCLM). Several studies have shown beneficial effect of ASA on primary prevention of CRC and the investigators group and others have shown a potential association of ASA also taken after the diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo for a period of 3 years or till disease recurrence. The patients will be treated and followed up according to standard of care and the National Guidelines. The ASAC trial will be the first clinical interventional trial to assess the beneficial role of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRC liver metastases if the study shows a beneficial effect. This trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality of Life and the cost-effectiveness.

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases

This study aims to evaluate the effectiveness and safety of combining low-dose radiotherapy to the intestines with immune checkpoint inhibitors (ICIs) in patients with liver metastases from solid tumors. Liver metastases often create an "immune desert" that makes immunotherapy less effective. Recent research has shown that low-dose irradiation of the gut (1 Gy) can reshape the gut microbiome and activate the immune system, potentially reversing resistance to immunotherapy. This is a prospective, single-arm, single-center cohort study. We plan to enroll 120 patients with liver metastases from non-small cell lung cancer (NSCLC), colorectal cancer, or pancreatic cancer. All participants will receive a single low dose of radiotherapy to the intestine (1 Gy), followed by standard immune checkpoint inhibitors and chemotherapy. The main goal of this study is to see how well the liver metastases respond to this combined treatment. We will also monitor survival, side effects, and changes in the gut bacteria and blood immune markers to understand how this treatment works. This strategy may provide a low-cost, low-toxicity new option for patients whose liver metastases have stopped responding to standard immunotherapy.

Therapeutic Efficacy and Safety of Ultrasound-Guided Microwave Ablation for Hepatic Metastatic Nodules

The liver is one of the most common organs where cancer cells spread (metastasize) from other parts of the body, especially from gastrointestinal cancers such as colorectal cancer. While surgical removal of liver tumors has traditionally been the standard treatment, most patients are not candidates for surgery due to tumor location, number of lesions, or underlying liver function. For these individuals, minimally invasive local therapies such as microwave ablation (MWA) provide an alternative approach to eradicate tumor tissue while preserving healthy liver parenchyma. Microwave ablation delivers localized high-frequency electromagnetic energy through a thin needle antenna placed percutaneously into the liver tumor. The generated heat induces rapid coagulative necrosis, destroying cancer cells within the target area. In this study, real-time ultrasound combined with CT image-fusion navigation is used to precisely position the ablation antenna within each nodule. The primary purpose of this study is to assess the therapeutic efficacy and safety of ultrasound-guided percutaneous microwave ablation for patients with liver metastases. Participants receive microwave ablation for their target liver tumors and are evaluated with contrast-enhanced CT or MRI at 1 month post-procedure to determine the rate of complete tumor ablation. Patients are then monitored longitudinally at 3, 6, 9, and 12 months to evaluate safety and check for local tumor recurrence.

CT Radiomics and Deep Learning-Based Non-Invasive Model for Tracing Primary Sites of Adenocarcinoma Liver Metastases: Automatic Differentiation of Multiple Primary Digestive Tumors

This is a retrospective observational study. Liver metastasis occurs frequently in digestive-system cancers. Identification of the primary tumor source of liver metastasis may pose clinical challenges. Biopsy is an invasive procedure associated with potential sampling errors. This study aims to develop and validate a non-invasive artificial-intelligence model based on contrast-enhanced CT images. The model integrates CT radiomics and deep learning to automatically determine the primary origin of adenocarcinoma liver metastases, including gastric adenocarcinoma, colorectal adenocarcinoma, biliary/gallbladder adenocarcinoma, and pancreatic ductal adenocarcinoma. The investigators will retrieve historical medical records and de-identified abdominal contrast-enhanced CT images from patients diagnosed at West China Hospital, Sichuan University between January 2015 and August 2026. No new intervention or treatment will be administered to participants in this study.

Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases

This clinical trial aims to assess whether the addition of bevacizumab to atezolizumab and chemotherapy can improve response to treatment and progression-free survival in patients with extensive-stage small cell lung cancer (ES-SCLC) with liver metastases. The main questions it aims to answer are: * In patients with ES-SCLC with liver metastases, can bevacizumab in combination with atezolizumab and chemotherapy prolong the length of time that the cancer does not progress? * Is bevacizumab safe and tolerable when combined with atezolizumab and chemotherapy in patients with ES-SCLC and liver metastases? The study treatment includes two phases: * Induction phase: bevacizumab will be administered in combination with atezolizumab and chemotherapy on a 21-day cycle for four cycles. * Maintenance: atezolizumab and bevacizumab will be administered every 21 days for up to 12 months, or until unacceptable toxicity or disease progression. Participants will undergo blood tests every 3 weeks and tumor assessments every 6 weeks.

Non-Contrast Versus Contrast-Enhanced MRI in Colorectal Liver Metastases

This prospective study aims to compare the diagnostic performance of a non-contrast abbreviated MRI protocol with a contrast-enhanced MRI protocol for the detection and follow-up assessment of colorectal liver metastases.

Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a "control group" of participants who drop out of study prior to transplantation due to reasons other than cancer progression.

SAMe in Prevention of Oxaliplatin-associated Liver Injury

This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.

Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases

If an abbreviated hepatobiliary phase (HBP) protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.

Local Ablation Plus Systemic Therapy for Metachronous Liver and/or Lung Oligometastases From Nasopharyngeal Carcinoma

This single-center, open-label, randomized phase II trial evaluates whether CT-guided local ablation of liver and/or lung oligometastases, added to systemic therapy, improves the objective response rate compared with systemic therapy alone in patients with metachronous liver and/or lung oligometastases (no more than 5 lesions, each 3 cm or smaller) from nasopharyngeal carcinoma.

Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study.

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is: • Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival? Participants will: * Receive chemotherapy treatment per standard procedure. * Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic. * Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit. * Participate in genetic testing, as a part of the standard of care for the treatment.

Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques

To compare 2 different image creation/processing techniques during a standard CT scan in order to "see" problems in the liver and learn which method provides better image quality. The techniques use new artificial intelligence software to decrease image noise, which helps the radiologist to evaluate.

End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.

Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System. A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

Background: Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person's body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver. Objective: To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver. Eligibility: Adults at least 18 years old with colorectal metastases to the liver Design: Participants will be screened with: Medical history Physical exam Heart, blood, and urine tests Scans Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it. Participants will get treatment in 28-day cycles. Every Day 1, they will have physical exam, symptom review, and blood tests. Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port. Every 12 weeks, they will have a scan. Tissue samples may be taken during the study. When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing.