Colon Cancer

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

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 Trifluridinetipiracil 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 12a 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 potential usefulness of 18F-FAPI-04 positron emission tomographycomputed tomography PETCT and positron emission tomographymagnetic resonance imaging PETMR for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PETCT and PETMR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value SUVmax and tumor to background ratio TBR. The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.

Researchers are evaluating 18F-grazy-02 PETCT imaging to study its safety and usefulness in monitoring immunotherapy treatments for patients with lymphoma or solid tumors, including lung cancer and melanoma. This diagnostic trial involves adults aged 18 to 75 years and focuses on immunotherapy approaches such as immune checkpoint inhibition and CAR-T cell therapy. The study is conducted in an open-label format, meaning both researchers and participants know the treatment being administered. Participants will receive an intravenous injection of 18F-grazy-02 at a dose of 2.96-3.7 MBqkg body weight. After injection, a total-body PETCT scan using a uEXPLORER scanner will be performed to image granzyme B expression. This imaging process occurs during the study period, which includes phases 1 and 2, to assess both safety and early monitoring capability of this tracer with immunotherapy. During the trial, participants will undergo PETCT imaging procedures and clinical monitoring to assess adverse events and biodistribution of 18F-grazy-02 over one year. The study also evaluates the ability of this PET tracer to monitor immunotherapy responses over a longer period of three years. Participants will be assessed for their health status, including ECOG performance score and ability to complete imaging procedures. The total study duration extends until December 2028, ensuring comprehensive safety and clinical data collection.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT 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, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT 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 PETCT 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-fluorouracilleucovorin 5FULV 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 21 ratio to one of two groups. The first group receives 5FULV 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 berberines 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 12a 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 PETCT 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.