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NCT07536113
This is an observational, retrospective, international and multicenter study funded by Fondazione Oncologia Niguarda ETS to assess the efficacy of anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients screened for RAS/BRAF/PIK3CA ctDNA status on liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The study will collect molecular, clinical and outcome data of patients already available at participating centers.
NCT07042685
This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.
NCT07228832
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)
NCT07446387
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.
NCT07381764
This study is a phase II, open-label, multicenter clinical trial designed to evaluate two different treatment options for patients with metastatic colorectal cancer whose disease has progressed after standard therapies. The study compares a rechallenge treatment using irinotecan plus cetuximab with the current standard of care, trifluridine/tipiracil plus bevacizumab, as third-line therapy. Patients enrolled in the study are selected based on specific molecular characteristics of their cancer, identified through circulating tumor DNA analysis from a blood sample. The main purpose of the study is to determine whether the rechallenge with irinotecan and cetuximab leads to a higher tumor response rate compared with trifluridine/tipiracil plus bevacizumab. Secondary objectives include evaluating progression-free survival, overall survival, safety, and quality of life. Patients will be randomly assigned to one of the two treatment groups and will receive treatment until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be assessed using standard imaging techniques according to RECIST criteria.
NCT07286695
Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with chemotherapy. Trifluridine/tipiracil plus bevacizumab is also a standard treatment for mCRC. This study aims to explore the efficacy and safety of fruquintinib combined with trifluridine/tipiracil versus bevacizumab combined with trifluridine/tipiracil in the treatment of patients with advanced metastatic colorectal cancer who failed standard chemotherapy.
NCT06784947
The goal of this study is to learn if a new combination treatment is effective for patients with microsatellite stable, advanced colorectal cancer. The study treatment combines 3 drugs: atezolizumab, bevacizumab, and tiragolumab. The main questions the study aims to answer are: 1. Does the study treatment effectively treat colorectal cancer? 2. Is the study treatment safe for patients with colorectal cancer? 3. How does the study treatment effect the immune system in patients with colorectal cancer? Participants in this study will receive the study treatment and undergo checkups, laboratory tests, and imaging tests for monitoring. Some participants will also undergo tumor biopsies.
NCT06887218
This is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU/LV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting. Patients will be randomly assigned in a 2:1 ratio between 5FU/LV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab. Arm 1 (Treatment Arm) will consist of the 5FU/LV administered to 38 patients as (LV \[400 mg/m² IV over 120 minutes\], followed by 5FU \[400 mg/m² IV bolus then 2400 mg/m² IV infusion over 46 hours\] in 2-week cycles) and regorafenib will be administered dose of 80-120 mg per day with weekly 40 mg per day increases to a maximum of 120 mg per day for 3 weeks on /1 week off until disease progression, up to 12 cycles of treatment. Arm 2 (Control Arm) received by an additional 19 patients, will be given as FTD-TPI, administered orally, BID, at a starting dose of 35 mg/m2 of body-surface area, on days 1 through 5 and on days 8 through 12 every 28 days. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered intravenously on days 1 and 15. The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.
NCT06944548
APACOL is a pilot, bicentric, randomised, open-label, prospective, category 2 study. The presence of colon cancer modifies blood lipid parameters which are likely to have an impact on the efficacy of anti-cancer treatments. Previous data support the hypothesis that appropriate physical activity could modify the blood lipid parameters involved in chemoresistance in patients with metastatic colorectal cancer. The aim of the APACOL study is to investigate the impact of modulating the frequency (volume per week) of physical activity recommended by INCa on the variation in lipid parameters involved in chemoresistance in patients with metastatic colon cancer, with a reference level of these lipid parameters in people without cancer provided by the participation of volunteers who are not ill. The expectations at the end of this study are an improvement in the patient's quality of life / an improvement in the tolerance and efficacy of the chemotherapy treatment / identification of the frequency of APAs needed to vary the lipid metabolism involved in chemoresistance.
NCT04627142
This study is open to adults with advanced bowel cancer (colorectal cancer) with a KRAS mutation. This is a study in people for whom previous treatment was not successful and surgery is not a treatment option. The purpose of this study is to find the highest dose of BI 1701963 that people with bowel cancer can tolerate when taken together with a medicine called irinotecan. The study also tests whether BI 1701963 in combination with irinotecan is able to make tumours shrink. BI 1701963 may help to turn off KRAS. Activating KRAS mutations make tumours grow. Irinotecan is a medicine to treat bowel cancer. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, participants take BI 1701963 as tablet once a day and get irinotecan as infusion every two weeks. The doctors regularly monitor the size of the tumour. The doctors also collect information on any health problems of the participants.