Clinical Research Directory

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer

P (Population): Patients with advanced colorectal cancer who have failed at least two prior lines of therapy. I (Intervention): Radiotherapy, immunotherapy, and fruquintinib. C (Comparator): Single-arm study with no control group. O (Outcomes): Safety, tolerability, and preliminary efficacy of the combination treatment. S (Study design): This is a phase II, single-arm clinical study. Radiotherapy will be delivered at 25-50 Gy in 5 fractions, including dose schedules of 40 Gy in 5 fractions and 50 Gy in 5 fractions, combined with fixed-dose immunotherapy and fruquintinib. The study plans to enroll 32 participants.

Study of Varsetatug Masetecan in Combination With Anti-Cancer Therapies in Colorectal Cancer

This is a non-registrational Phase 1/2, multicenter, open-label trial to evaluate the efficacy and safety of varsetatug masetecan combined with anti-cancer therapies in participants with unresectable metastatic colorectal cancer in the second line treatment setting.

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors

This is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type: * Gynecologic cancer (ovarian or endometrial) * Colorectal cancer * Pancreatic cancer * Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas * Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Alaunos Therapeutics Inc.'s (Alaunos) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol. Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.

NURSE-led Geriatric Assessment in Older Colorectal Cancer Patients

Older colorectal cancer patients frequently present with frailty, comorbidity, and other age-related vulnerabilities that may affect treatment tolerance and outcomes. Geriatric assessment is recommended for older adults with cancer but remains underutilized. The NURSE-GA study aims to evaluate the feasibility of a nurse-led geriatric assessment intervention prior to treatment decision-making for patients aged 70 years and older who are newly diagnosed with colorectal cancer and have a Clinical Frailty Scale score of 4 or higher. Trained nurses will perform structured geriatric assessments and identify optimization needs and referral needs. The study will evaluate intervention delivery, patient satisfaction, clinical outcomes, usability among multidisciplinary team members, self-efficacy among nurses, and recruitment and retention rates.

A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

This clinical trial evaluated the safety and efficacy of KVA12123, subsequently designated TBS-2025, alone or combined with pembrolizumab in patients with advanced solid tumors. The study included dose escalation and planned dose expansion phases. Only the dose escalation phases were conducted. The planned dose expansion phase were not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern. The study sought to assess the safety of KVA12123 \[TBS-2025\] given alone or with pembrolizumab and to identify appropriate doses for future clinical trials. Participants in the doses for future clinical trials. Participants in the dose escalation phases visited study sites for treatment and safety assessments. These assessments included blood samples, imaging scans, physical examinations, and heart function tests.

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

PRE-ISPY Phase I/II Oncology Platform Program

PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.

Prehabilitation in High-risk Oncologic Surgery

The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally. The main questions this study aims to answer are: 1. Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery? 2. Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery? 3. Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment? Participants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days. Researchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.

Early Discharge After Colorectal Surgery

RECUPERA-C is a prospective observational pilot study evaluating the feasibility and safety of an early discharge strategy within 48 hours after minimally invasive colorectal surgery. The study will assess whether patients can meet predefined clinical and functional discharge criteria, and will identify factors that may prevent early discharge. C-reactive protein and neutrophil-to-lymphocyte ratio will also be evaluated as exploratory markers of postoperative complications.

The AIDPRO-CRC Trial

The AIDPRO-CRC trial aims to improve outcomes for patients undergoing surgery for colorectal cancer by using artificial intelligence (AI) to assist surgeons in risk assessment. The trial will evaluate whether AI can help surgeons better predict the risk of complications and death, leading to improved care, fewer complications, and better use of healthcare resources. In this nationwide, randomized clinical trial, participants will be divided into two groups. One group will have their risk assessed by a surgeon using standard clinical methods, while the other group will have their risk assessed by a surgeon using AI assistance. Based on the risk level, patients will receive varying levels of perioperative care. The AI-assisted risk assessment aims to tailor the treatment more precisely to each patient's individual needs, precisely allocating care to those who need it to more efficiently allocate heath system resources while having no deterioration in patient outcomes. The primary hypothesis is that AI-assisted risk assessment will lead to more efficient and economic patient care without a deterioration in patient outcomes. The trial also aims to explore clinician satisfaction with the platform and its perceived effect. This is paired with a substudy exploring the variability of suggested treatment plans by clinicians with and without access to the MDT presentation platform. The trial will include patients at seven hospitals across Denmark, involving patients diagnosed with colorectal cancer who are scheduled for curative surgery. All patients will receive standard treatment according to national guidelines, with the only difference being the modality of risk assessment. For the evaluation of the clinicians satisfactory with the device and the substudy of variability of suggested treatment plans, the trial will enroll clinicians using the device. This study is a researcher-initiated, nationwide, randomized clinical trial involving patients diagnosed with colorectal cancer across eight hospitals in Denmark. Participants will be randomly assigned to one of two groups: AI-assisted risk assessment or standard surgeon-led assessment. The intervention focuses on optimizing perioperative care based on individual risk levels determined by either AI or the surgeon's clinical judgment. The study builds on a successful pilot project (AID-SURG) that showed promising results in reducing complications, hospital stays, and readmissions.

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)

The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075.

Impact of Obesity on Textbook Outcome Achievement in Minimally Invasive Colorectal Cancer Surgery

Textbook Outcome (TO) is a composite quality measure that integrates multiple perioperative endpoints to provide a comprehensive assessment of surgical quality. Although obesity has been associated with adverse outcomes after colorectal surgery, its impact on achieving TO remains unclear, particularly in the era of minimally invasive surgery. This study aimed to evaluate the association between body mass index (BMI) and TO achievement in patients undergoing minimally invasive colorectal cancer surgery.

EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

The purpose of this study is to determine the immunogenicity of the CIMAvaxEGF® vaccine (that is, its effectiveness in inducing an anti-tumor immune response) in patients with metastatic KRAS/NRAS/BRAF wild-type gene colorectal cancer, when given in combination with standard therapies used in the treatment of advanced colorectal cancer.

A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

Advanced Endo-therapeutic Procedure : Registry-based Observational Study

Advanced therapeutic endoscopy procedures are of increasing importance to provide minimal invasive treatment for GI diseases. The Centre Hospitalier de l'Université de Montréal as tertiary university center is dedicated to increase the availability of therapeutic endoscopy procedures for our population in Montreal and Quebec. Advanced endotherapeutic endoscopy can replace surgery for treatment of benign and malign GI diseases and the aim of this registry-based study is to improve quality related to advanced endotherapeutic endoscopy, as it will provide quantitative means to assess advanced endotherapeutic practice and may identify practices of low quality (possible intervention) or high quality (desired).

Shield Post-Approval Study Protocol

The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis

The RaP-DMac-LiMe study (Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis) is a monocentric, non-profit observational study promoted by Fondazione Policlinico Universitario A. Gemelli IRCCS. Its primary aim is to identify immunological, genomic, and radiomic biomarkers associated with recurrence risk in patients with colorectal liver metastases (CRLM) undergoing curative-intent liver resection. The study is based on the need to improve prognostic stratification in CRLM by integrating information from the tumor immune microenvironment, tumor genomics, radiomics, and clinical data. Particular attention is given to myeloid immune cells, especially dendritic cells and tumor-associated macrophages, whose role in metastatic progression and recurrence remains insufficiently understood. The primary objective is to assess the association between myeloid immune profiles and recurrence risk through integrated molecular, spatial, genomic, and radiological analyses. Secondary objectives include characterizing the transcriptomic and genomic features of dendritic cells and macrophages, identifying radiomic and circulating tumor DNA (ctDNA) biomarkers, and evaluating their potential as non-invasive tools for recurrence prediction and patient stratification. The study includes a retrospective cohort of approximately 160 patients treated between 2009 and 2023 and a prospective cohort of approximately 50 patients who will be followed for 24 months. Tumor tissue samples, peripheral blood, imaging data (CT/MRI), and clinical information collected during routine care will be analyzed without introducing any experimental interventions or deviations from standard clinical practice. Analyses will include transcriptomic profiling, multiplex spatial characterization of immune cells, circulating tumor DNA sequencing using next-generation sequencing technologies, radiomic feature extraction, and integration of all data using statistical and machine learning approaches. Predictive models will be trained on retrospective data and independently validated in the prospective cohort. The primary endpoint is the prediction of colorectal liver metastasis recurrence within two years after liver resection. Ultimately, the study aims to develop and validate a multimodal predictive model integrating immune, genomic, radiomic, and clinical variables to improve recurrence risk assessment and support personalized patient management. The overall study duration is 36 months. All procedures will be conducted in accordance with ethical standards and data protection regulations, with samples and clinical data pseudonymized and handled in compliance with the GDPR.

Multicentric National Italian Analysis of Textbook Outcome in Colorectal Cancer Surgery

Colorectal cancer (CRC) is the third most common malignancy worldwide, with more than 1.9 million new cases reported annually. Survival among patients with CRC depends on several factors, including disease stage at diagnosis, the patient's clinical condition, tumour characteristics, and treatment modalities. Despite advances in surgical techniques, active involvement in clinical, translational, and basic research, and improvements in perioperative care, substantial disparities in short- and long-term outcomes persist across healthcare providers and countries. To reduce these variations and improve the quality of cancer care, several metrics have been used to evaluate hospitals, therapeutic approaches, and surgical outcomes. In response to these needs, a composite measure known as "Textbook Outcome" (TO) was developed. It encompasses multiple favourable outcomes and requires patients to meet all essential quality-of-care criteria for a given procedure. TO serves as an effective predictor of survival and is recognised as an indicator of the quality of hospital care. This study aims to investigate the value of TO as an indicator of clinical outcomes and quality of care in the surgical treatment of colorectal cancer. The primary objective is to assess the achievement of Textbook Outcome criteria in colorectal cancer surgery performed by Italian surgeons. Textbook Outcome is defined by the fulfilment of six key parameters: in-hospital survival, defined as the absence of death during hospitalisation or within 30 days after surgery; radical resection, defined as an R0 resection with at least 12 lymph nodes examined; absence of reoperation; absence of an unplanned stoma; absence of major adverse events, classified according to the Clavien-Dindo criteria as grade III or higher, within 30 days after surgery; and a hospital length of stay of 14 days or less without unplanned readmission. The simultaneous achievement of all six parameters constitutes the optimal outcome, defined as Textbook Outcome. The secondary objective is to assess the consistency with which surgeons meet TO criteria during colorectal surgery and to identify patient- and procedure-related factors associated with failure to achieve TO. Through a detailed analysis of these factors, the study aims to identify the variables influencing TO failure and to determine which aspects of clinical practice or patient characteristics represent the main barriers to meeting these quality standards. The usefulness of TO as a quality indicator in the surgical management of colorectal cancer will also be evaluated by examining which individual unmet components are most frequently associated with unfavourable clinical outcomes, with particular attention to the different clinical presentations of the disease. The study will include all adult patients admitted to the participating surgical departments with a diagnosis of colorectal cancer between 1 January 2022 and 31 December 2024. Patient data will be analysed retrospectively. Demographic characteristics, comorbidity status, clinical and radiological findings, treatment strategies, and 30-day morbidity and mortality will be evaluated. Data will be entered into an online database between 1 January 2025 and 31 May 2025. The study will last 12 months: the first five months will be dedicated to data collection and the subsequent seven months to data analysis. The study is scheduled to begin in January 2025 with the commencement of data collection. The sample size required to achieve 80% statistical power, with a margin of error of ±5% at a 95% confidence level, is 324 patients. Continuous variables not following a normal distribution will be expressed as medians with interquartile ranges (IQRs), whereas normally distributed continuous variables will be reported as means with standard deviations (SDs). The Mann-Whitney U test will be used to compare non-normally distributed continuous variables between groups. Normally distributed continuous variables will be compared using the independent-samples t-test or one-way analysis of variance (ANOVA), as appropriate. Categorical variables will be reported as frequencies, and proportions will be compared between groups using the χ² test. Survival curves will be estimated using the Kaplan-Meier method and compared using the log-rank test. Prognostic factors for survival will be assessed using multivariable Cox proportional hazards regression. Statistical significance will be set at a two-sided P value of \< .05.

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. (CRC and melenoma cohorts are now closed to new patients)

Colorectal Cancer Screening Outreach

This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.

The French E3N Prospective Cohort Study

The French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women. The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years. Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%. A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women. Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.

The Impact of AI-Assisted Nursing Care Intervention Within the Enhanced Recovery Framework on Outcomes of Colorectal Surgery Patients

Colorectal cancer is one of the most common cancers worldwide, affecting a large number of people each year (Bray et al., 2022). Surgical intervention remains the gold standard in treatment. However, advances in surgical techniques and increased effectiveness of neoadjuvant therapies have brought sphincter-preserving surgeries to the forefront, reducing the need for stoma creation compared to the past (Jo \& Wilson, 2025; Wang et al., 2025). Even without stoma creation, these patients face complex care needs in the post-discharge period, including changes in bowel habits, nutritional management, and adaptation to physical activity (Wang et al., 2025). Difficult-to-manage complications carry a high risk of readmission to the hospital. Patients receive limited support during the transition from the hospital to home and at home (Storm et al., 2024). Patients and their families are often left alone to manage home care until routine follow-up appointments. Patients, especially those poorly prepared for discharge, may not know how to perform care practices at home or what to watch out for in case of complications. Situations that are well managed in the hospital can spiral out of control upon inadequate follow-up after the patient returns home, leading to unplanned readmissions. Insufficient postoperative patient follow-up can cause anxiety in patients, leading to readmissions due to the inability to manage the home care process effectively (Storm et al., 2024). Although accelerated recovery after surgery (ERAS) is known to shorten hospital stays (Gustafsson et al., 2025; Gustafsson et al., 2019), studies show varying results regarding readmissions, re-operations, developing complications, and survival (Coleman et al., 2006; Takchi et al., 2020; Lee et al., 2022). These variable results highlight the need for a structured discharge process and home care management for patients who undergo ERAS and are discharged home earlier. In the study by Takchi et al. (2020), a scheduled phone call was proposed as the final step in advanced recovery recommendations and presented as a pilot study. The study reported that each patient contacted reported at least one symptom and personal care need (Takchi et al., 2020). The scheduled phone calls proposed by Takchi et al. (2020) are an important monitoring mechanism in the recovery process; however, they are insufficient. Supporting this monitoring process with a structured discharge management and AI-powered digital video accessible to the patient at any time, extends the continuity of care to a digital dimension. It is reported that AI-powered multimedia tools, whose use is increasing with the transformation in health technologies today, reduce cognitive load by concretizing complex surgical processes with audiovisual materials and improve patients' self-care skills regardless of their health literacy level (Mendoza-Pinto et al., 2025). "Content prepared with generative artificial intelligence algorithms, in particular, increases the retention of information and the patient's digital health literacy compared to traditional educational materials (Zaretsky et al., 2024). This study aims to both structure the discharge and post-discharge follow-up process, which is included in ERAS protocols to a limited extent, and to increase the patient's readiness for discharge, improve patient outcomes, and facilitate home care management using AI-assisted educational videos. Thus, the study significantly points to a fourth step, which is included in ERAS guidelines in the pre-operative, intra-operative, and post-operative phases and is felt to be missing: the discharge and home follow-up process.

Decision Counseling and Follow-up for Shield+ Patients

Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.

Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.