Colorectal Cancer

This research evaluates the effectiveness and safety of adding Thymalfasin to a combination of Regorafenib and Tislelizumab in patients with advanced colorectal cancer that is mismatch repair proficient (pMMR) or microsatellite stable (MSS). This Phase II, multicenter, open-label, randomized controlled study compares a triple therapy group receiving all three drugs with a double therapy group receiving only Regorafenib and Tislelizumab. The goal is to assess progression-free survival over 48 weeks in patients who have failed standard treatments. Participants are randomly assigned to one of two treatment groups. The triple therapy group receives Thymalfasin (4.8 mg subcutaneously twice weekly) combined with oral Regorafenib (starting at 80 mg daily for two weeks with a one-week break, potentially increasing to 120 mg daily) and intravenous Tislelizumab (200 mg every 21 days). The double therapy group receives Regorafenib and Tislelizumab without Thymalfasin. Treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including imaging to monitor tumor response using iRECIST criteria. Laboratory tests, physical exams, and adverse event monitoring are conducted to evaluate safety and treatment effects. The study plans to enroll 52 subjects over nine months with a total duration of 15 months, including follow-up to measure progression-free survival and monitor overall safety.

Researchers are evaluating a "wait-and-see" approach for patients with rectal cancer who respond completely to neoadjuvant chemoradiotherapy. This study aims to provide both short-term and long-term data on cancer control and patient function when surgery is avoided in good responders. The research also seeks to establish a national network of expert centers to improve organ-preserving care and create a registry to gather more evidence about this treatment strategy. The standard treatment for locally advanced rectal cancer typically involves chemoradiotherapy followed by surgery. In this study, patients who show a complete clinical response after treatment will be observed without immediate surgery under a "wait-and-see" policy. The study is a multicenter prospective observational cohort and implementation study, focusing on patients aged 18 or older who have had a long course of chemoradiotherapy or a short course with a long waiting interval. The main goal is to track disease-free survival without tumor regrowth over two years. Participants will be closely monitored using clinical exams, endoscopy, and advanced MRI scans to confirm their response and detect any regrowth early. Researchers will measure outcomes such as two-year disease-free survival, regrowth rate, local control, overall survival, quality of life, and the ability of centers to provide high-quality organ preservation care. Patients will undergo intensive follow-up to ensure safety and gather comprehensive data on the effects of this less invasive approach over time.

Researchers are studying how COVID-19 affects patients with cancer who are receiving different types of anti-cancer treatments. Since cancer patients are more vulnerable to the virus, many countries have prioritized their vaccination, but these patients were not included in the original vaccine trials. This study aims to understand the changes in protective antibodies after vaccination or natural infection in cancer patients undergoing chemotherapy, targeted therapy, or immunotherapy, as well as to explore how aging impacts immune responses. The study enrolls adults over 20 years old who have solid organ cancers and are either receiving anti-cancer therapies or have been disease-free for at least six months. Participants include those fully vaccinated with any COVID-19 vaccine or those who agree to complete vaccination later. The research involves monitoring antibody levels related to COVID-19 over time among these patients to observe trends in immunity. Participants will be followed for up to 12 months, with antibody tests conducted at 3, 6, 9, and 12 months to measure neutralizing and spike protein antibodies. The study collects data on how different cancer treatments affect antibody responses and monitors safety through regular outpatient follow-ups. Participation includes consenting to testing and follow-up visits to support understanding of vaccine efficacy and infection progression in cancer patients.

Researchers are conducting a phase II, multicenter, open-label trial to investigate the combination of Fruquintinib and Tislelizumab in patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) metastatic colorectal cancer who do not have active liver metastases. The study aims to evaluate the effectiveness of this combination in comparison to a control treatment for this specific group of patients. Participants will be randomly assigned to one of two treatment groups. The experimental group will receive oral Fruquintinib (5 mg daily for 21 days in each 28-day cycle) along with intravenous Tislelizumab (400 mg every 42 days). The control group will be treated with oral Trifluridine/tipiracil (35 mg/m2 twice daily on days 1-5 and 8-12 of each 28-day cycle) plus intravenous Bevacizumab (5 mg/kg every 14 days). Treatment continues until disease progression, unacceptable side effects, patient choice, or a maximum of 15 months. During the study, patients will undergo regular assessments including imaging to monitor disease status and safety evaluations. Follow-up will continue for up to 18 months after the last patient enrolls or until death, withdrawal, or loss to follow-up. The main outcome measure is the efficacy of Fruquintinib combined with Tislelizumab in this patient population over a 54-month period.

Researchers are investigating the safety, tolerability, distribution in the body, radiation dose, and early anti-tumor effects of 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in adults with certain advanced solid tumors that express PD-L1 or have specific genetic markers. This Phase 0/1, first-in-human study aims to find the recommended doses for future studies by evaluating both imaging and treatment doses in participants with cancers such as lung, breast, melanoma, head and neck, endometrial, and others with relevant mutations or markers. The study includes several periods: a screening period lasting up to 4 weeks, followed by a Phase 0 imaging period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and radiation exposure over about 2 weeks. After this, participants enter the Phase 1 treatment period involving dose escalation of the therapeutic 177Lu-RAD204 with cycles lasting 6 weeks. Participants may receive multiple cycles if they benefit clinically and have acceptable safety and organ radiation levels. Dose limiting toxicities are monitored for 6 weeks after the first treatment dose, with flexibility for altered schedules if needed. Throughout the study, participants undergo imaging scans, safety assessments, and dosimetry measurements to track how the drug moves and acts in the body. Researchers measure various outcomes including time activity curves, radiation dose, pharmacokinetics, and biokinetics over 72 hours, as well as safety and tolerability over 6 weeks. The study carefully monitors the recommended doses for future exploration, and participants may be followed for clinical benefit and adverse events during treatment cycles and follow-up periods.

Researchers are studying 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, to understand its safety, how it moves and distributes in the body, and its preliminary effectiveness against certain solid tumors. This study focuses on patients aged 18 and older with relapsed or refractory locally advanced, inoperable, or metastatic solid tumors including castration-resistant prostate cancer, colorectal cancer, various lung cancers, head and neck squamous cell carcinoma, ovarian, cervical, endometrial, triple negative breast, and esophageal squamous cell carcinoma. The trial has two phases to evaluate safety and early anti-tumor activity, using advanced study designs to identify appropriate dosing and response rates. The study involves two main phases: Phase 1 is a dose escalation phase where participants receive intravenous infusions of 177Lu-BetaBart every 6 weeks to determine the maximum tolerated dose and recommended dose for Phase 2. Phase 2a is a dose expansion phase conducted at the recommended dose to further assess safety and early anti-tumor effects. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period. Participants will undergo various assessments including imaging scans and laboratory tests to monitor disease progression, treatment safety, and biological responses over periods up to 6 weeks for Phase 1 and up to 30 weeks for Phase 2a. Researchers will track adverse events, dose recommendations, and measure tumor activity using biochemical markers and imaging. Long-term safety and treatment effects will be followed after the treatment periods to gather comprehensive clinical data.

Researchers are evaluating the usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) in diagnosing primary and metastatic cancer lesions. The study focuses on detecting cancer recurrence and assessing pathological response in patients with various types of malignant tumors. This preliminary study uses histopathology and follow-up results as the gold standard to measure diagnostic performance. Participants receive an injection of the imaging agent 18F-FAPI-04 before undergoing PET/CT or PET/MR scans. These scans are used to quantify tumor uptake by measuring the maximum standard uptake value (SUVmax) and tumor-to-background ratio (TBR). The study compares the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the two imaging methods. During the study, patients with suspected or diagnosed malignant tumors undergo imaging assessments. Researchers collect imaging data and follow up with participants to confirm findings. The main outcome measured is the diagnostic performance of these imaging techniques over one year. Participants must provide informed consent, and safety monitoring is part of the study process. The age range for participants is 18 to 90 years old.

Researchers are evaluating the diagnostic usefulness of a new protein-specific imaging probe called 18F-T2 in PET/CT scans for participants with solid tumors that may express high levels of the CAIX protein. This trial also aims to assess the safety, tolerability, and radiation exposure from using 18F-T2. The study includes various types of cancers such as renal cell, urothelial, colorectal, cervical, ovarian, head and neck, liver, bile duct, lung, breast, pancreatic, endometrial cancers, and Von Hippel Lindau Disease. Participants will receive an intravenous injection of 18F-T2 at a dose of 0.05-0.10 mCi/kg. About 60 minutes after the injection, they will undergo combined CT and PET imaging sessions to evaluate tumor detection using this new probe. The study focuses on measuring the diagnostic sensitivity and specificity of 18F-T2 PET/CT and monitoring adverse events shortly after injection. During the study, participants will be closely monitored for side effects within 24 hours of receiving the injection. Researchers will collect imaging data from the PET/CT scans and assess diagnostic accuracy up to one month after study completion. Participants must provide informed consent and comply with all study requirements throughout their involvement. The total duration and follow-up involve safety and diagnostic performance evaluation after the imaging procedure.

Researchers are investigating a treatment for patients with metastatic colorectal cancer who have already tried two previous therapies. This phase II trial aims to compare the effectiveness and safety of a combination of 5FU/LV and regorafenib against another treatment involving trifluridine-tipiracil plus bevacizumab. The goal is to determine if the 5FU/LV with regorafenib is not worse than the other treatment in this third-line setting. Participants will be randomly assigned in a 2:1 ratio to one of two treatment groups. The first group receives 5FU/LV through intravenous infusion every two weeks, combined with regorafenib taken orally daily with dose increases over a 3-week period followed by 1 week off, up to 12 cycles or until disease progression. The second group takes trifluridine-tipiracil orally twice daily on specific days in a 28-day cycle, along with intravenous bevacizumab on days 1 and 15, continuing up to 12 cycles or until the cancer worsens or side effects become unacceptable. Throughout the study, participants will be monitored from the start of treatment until disease progression, unacceptable side effects, or withdrawal, for up to 18 months. Researchers will assess treatment effectiveness and safety during this time. Patients' health will be evaluated regularly to observe how well the treatments control the cancer and to track any adverse effects experienced.

Researchers are investigating a new treatment approach for metastatic colorectal cancer (mCRC) in patients whose tumors have MGMT silencing and are microsatellite stable (MSS). This approach combines several chemotherapy drugs, including fluoropyrimidines, irinotecan, temozolomide, and bevacizumab, aiming to overcome resistance seen with single chemotherapies. The study includes phase 1b and phase 2 parts, focusing on safety, dosing, and effectiveness of this combination in patients not previously treated for advanced disease. The treatment regimen starts with an induction phase of four 28-day cycles combining 5-fluorouracil, leucovorin, irinotecan, temozolomide, and bevacizumab (FLIRT-bevacizumab), followed by a maintenance phase where 5-FU/LV and bevacizumab are given every two weeks along with oral temozolomide on days 1 to 5 every 28 days. Doses of temozolomide are escalated during treatment to find the recommended phase 2 dose. Bevacizumab, irinotecan, leucovorin, and 5-fluorouracil are administered intravenously every two weeks. Participants undergo tumor assessments before treatment and every eight weeks to monitor disease progression, side effects, and treatment response. The study tracks safety by identifying dose-limiting toxicities during the dose-escalation phase and evaluates the treatment’s efficacy over 24 months. Patients continue treatment until disease progression, unacceptable toxicity, withdrawal, or death. The phase 1b portion has been completed, and the phase 2 part is ongoing.