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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating factors that predict resistance to pembrolizumab, an immunotherapy drug used as the first treatment in patients with metastatic colorectal cancer that shows microsatellite instability or deficient mismatch repair. This study follows up on findings that about 20-30% of patients treated with pembrolizumab show primary resistance, highlighting a need to better identify which patients will benefit from this therapy and which may need other treatments. This research involves a national French cohort called CORESIM, combining both retrospective and prospective patient groups. Patients who started pembrolizumab treatment since February 2021 are included retrospectively, while new patients beginning pembrolizumab from February 2024 will be enrolled prospectively. Tumor samples and blood will be collected to analyze predictive biomarkers. The study expects to include about 600 patients over a 2-year enrollment period. Participants will be followed for 3 years to monitor outcomes and gather data on pembrolizumab resistance. Tumor archives and blood samples will be collected to support the research. The primary goal is to identify factors linked to treatment resistance. The study is observational, meaning it tracks patients receiving standard care without assigning treatments. This long-term follow-up helps researchers understand how different factors affect response to pembrolizumab in metastatic colorectal cancer.
Actively Recruiting
Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.