# Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients

Source: https://onco.cc/trials/nct03829462/  
OnCo record `nct03829462` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: NEXT-REGIRI
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT03829462: https://clinicaltrials.gov/study/NCT03829462

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [FOLFIRI (5-FU, leucovorin, irinotecan)](https://onco.cc/drugs/folfiri/), [Regorafenib](https://onco.cc/drugs/regorafenib/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct03829462.json