Rectal Cancer

This trial investigates treatment options for patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) metastatic colorectal cancer who do not have active liver metastases. It is a phase II, prospective, randomized, open-label study conducted across multiple centers. The study aims to evaluate the effectiveness of Fruquintinib combined with Tislelizumab compared to a control treatment in this specific patient group. Participants will be randomly assigned to one of two groups. One group will receive Fruquintinib orally once daily for 21 days in a 28-day cycle along with Tislelizumab given intravenously every 42 days. The other group will receive Trifluridine/tipiracil orally twice daily on specific days of a 28-day cycle plus Bevacizumab intravenously every 14 days. Treatment will continue until disease progression, unacceptable side effects, patient choice, or a maximum of 15 months. During the study, patients will undergo regular assessments including imaging scans to monitor disease status, evaluations of side effects, and quality of life measures. Follow-up will continue for up to 18 months after the last patient begins treatment or until death, withdrawal, or loss to follow-up. Researchers will primarily measure the efficacy of the Fruquintinib and Tislelizumab combination, along with overall survival, response rates, safety, and quality of life.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PET/CT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are investigating treatments for patients with metastatic colorectal cancer who have not responded to second-line therapy. This randomized phase II trial compares the combination of 5-fluorouracil/leucovorin (5FU/LV) with regorafenib against a combination of trifluridine-tipiracil (FTD-TPI) plus bevacizumab. The study aims to evaluate the effectiveness and safety of these treatments in this third-line setting. Participants are randomly assigned in a 2:1 ratio to one of two groups. The first group receives 5FU/LV given intravenously in two-week cycles along with regorafenib taken orally daily with dose escalation over three weeks followed by one week off, continuing up to 12 cycles or until disease progression. The second group receives FTD-TPI orally twice daily on specific days of a 28-day cycle and bevacizumab intravenously on days 1 and 15, also continuing up to 12 cycles or until disease progression or unacceptable side effects. During the study, participants will undergo regular assessments to monitor treatment effects and safety. Researchers will track the time from treatment start until disease progression, unacceptable toxicity, or withdrawal, assessing up to 18 months. Safety and tolerability will also be evaluated. The trial includes laboratory tests and clinical evaluations throughout the treatment period, with the possibility to withdraw at any time. Total participation duration depends on individual treatment response and tolerance.

Researchers are investigating a new treatment approach for metastatic colorectal cancer (mCRC) that combines several chemotherapy drugs with a drug that blocks blood vessel growth called bevacizumab. This study focuses on patients whose tumors have a specific genetic change called MGMT silencing and who have a stable microsatellite status. The goal is to test the safety and appropriate dose of this combination, as previous research shows that combining these drugs may overcome resistance seen with single treatments. The treatment includes 5-fluorouracil, leucovorin, irinotecan, temozolomide, and bevacizumab. It starts with an induction phase of four 28-day cycles given every two weeks, including continuous infusion of 5-fluorouracil and intravenous infusions of the other drugs. Temozolomide is taken orally in increasing doses over five days every 28 days. After the induction, patients without disease progression continue with maintenance treatment using 5-fluorouracil, leucovorin, bevacizumab, and oral temozolomide. The study uses a dose-escalation design to find the maximum tolerated dose or recommended dose for further testing. Participants will have tumor assessments at the start and every 8 weeks to monitor disease status and side effects. Safety, response to treatment, and quality of life are regularly evaluated using clinical exams and questionnaires. The study will continue treatment until the disease progresses, unacceptable side effects occur, or participants choose to stop. The phase 1b part determined the recommended dose of temozolomide, and the phase 2 part is ongoing to assess treatment effectiveness over two years.

Colorectal cancer is a common and serious disease that often develops from precursor growths called adenomatous polyps. This study evaluates the long-term effects of berberine hydrochloride, a drug previously shown to reduce recurrence of these polyps after removal. Researchers aim to see if the protective effects of berberine continue for up to six years after patients stop taking the medication. The study observes patients who were part of an earlier trial where they received either berberine or a placebo. It compares the recurrence rates of colorectal adenomas and other types of polyps at multiple intervals: within the first year, between one and three years, and between three and six years after stopping the drug. This retrospective follow-up helps assess berberine's long-term preventive effects. Participants will be monitored through medical records to track the recurrence of colorectal adenomas and other polyps over six years. Researchers will analyze outcomes such as the rate of traditional adenoma recurrence and the incidence of hyperplastic and serrated polyps. This study provides important information about the lasting impact of berberine on colorectal polyp recurrence after endoscopic removal.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.

Researchers are evaluating treatments for low anterior resection syndrome (LARS), a condition affecting bowel function after part of the rectum is surgically removed in rectal cancer patients. LARS can cause symptoms like urgency, incontinence, frequent bowel movements, constipation, and incomplete emptying. This trial compares a bowel management program using a retrograde rectal enema (RRE) with standard medical management to determine which approach better manages LARS symptoms. Participants are randomly assigned to one of two groups. One group receives a combination of medical management—including fiber, loperamide hydrochloride, and pelvic floor physical therapy—plus a self-administered RRE enema regimen for one year. The other group receives medical management alone for one year and may be referred for surgery if symptoms persist. Abdominal x-rays may be performed during the trial for participants using the RRE. Throughout the study, participants will be assessed using a validated LARS scoring tool and surveys to measure fecal incontinence and patient satisfaction up to one year after treatment starts. Follow-up visits occur at one month, three months, and one year after completing the intervention. The trial aims to evaluate effectiveness, feasibility, and symptom control of the treatments over this period.

Researchers are evaluating a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect aimed at increasing follow-up colonoscopy rates after abnormal fecal immunochemical test (FIT) results in patients at Federally Qualified Health Centers (FQHCs). Colorectal cancer screening using FIT is common in low-resource settings, but follow-up colonoscopy rates after abnormal results are low due to multiple barriers. This study compares the usual care with an enhanced care coordination approach to improve these follow-up rates in a large FQHC system. The study is a pragmatic, cluster randomized trial involving six clinics, divided into two groups: one receiving usual care with monthly electronic health record (EHR) reviews and standardized communication about abnormal FIT results, and the other receiving the Primary Care-GI Connect intervention. This enhanced intervention adds GI liaison coordination, patient navigation for scheduling GI appointments, standardized referral templates, colonoscopy education via informational sheets and a 20-minute video, and reminder text messages emphasizing the importance of follow-up colonoscopy. Participants will be monitored through regular EHR reviews and monthly assessments of intervention implementation quality over up to three years. Researchers will evaluate follow-up colonoscopy rates within 6, 9, and 12 months of abnormal FIT results, along with factors affecting implementation, time to colonoscopy, and cost-effectiveness. Participants may also be involved in ancillary studies including interviews and additional data collection. The study aims to understand the feasibility, value, and impact of this multilevel intervention on colorectal cancer screening adherence.