Colorectal Cancer

Researchers are evaluating the efficacy and safety of Thymalfasin combined with targeted immunotherapy drugs Regorafenib and Tislelizumab compared to Regorafenib and Tislelizumab alone in patients with advanced mismatch repair-proficient (pMMR) or microsatellite stable (MSS) colorectal cancer who have not responded to standard treatments. This Phase II randomized controlled study aims to compare progression-free survival between these two treatment approaches. The study will enroll 52 subjects across multiple centers with specific statistical assumptions guiding enrollment and analysis. Participants will be randomly assigned to one of two groups: a triple therapy group receiving Thymalfasin subcutaneously twice weekly along with oral Regorafenib and intravenous Tislelizumab, or a double therapy group receiving only Regorafenib and Tislelizumab. Regorafenib will start at 80 mg orally daily for two weeks followed by a one-week break, with an increase to 120 mg daily if tolerated. Tislelizumab is given by intravenous infusion once every 21 days. Treatment continues until disease progression according to iRECIST criteria or unacceptable side effects occur. During the study, participants will be monitored for disease progression and adverse events with regular assessments including imaging to measure tumor response. The primary outcome is progression-free survival at 48 weeks. Secondary outcomes include 18-week progression-free survival rate, objective response rate, disease control rate, and overall survival up to three years. Safety and tolerability will also be assessed throughout the trial. The total study duration includes enrollment over 9 months and follow-up for up to 15 months.

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 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-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 0/1 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

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 potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) 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 PET/CT and PET/MR 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 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.