{"entity":{"id":"nct03829462","kind":"trial","name":"Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients","aka":["NEXT-REGIRI"],"tldr":"A phase 3 trial of regorafenib and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle, active but no longer recruiting.","summary":"Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients is a phase 3, randomised interventional study registered as NCT03829462 by Institut du Cancer de Montpellier - Val d'Aurelle, with a registry enrolment figure of 377 participants, started 2019-03-28 and due to reach its primary completion in 2024-09-04. Interventions recorded: Regorafenib; Irinotecan. Conditions listed: Metastatic Colorectal Cancer (mCRC). Primary outcome: Overall Survival. Colorectal eligibility wording from the registry: \"* Histological documentation of adenocarcinoma of the colon or rectum\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03829462","url":"https://clinicaltrials.gov/study/NCT03829462"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["regorafenib","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03829462","phase":"3","setting":"A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","enrolled":377,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03829462/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"folfiri","kind":"drug","name":"FOLFIRI (5-FU, leucovorin, irinotecan)","route":"/drugs/folfiri/"},{"id":"regorafenib","kind":"drug","name":"Regorafenib","route":"/drugs/regorafenib/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}