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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.
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. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
377 enrolled.
95% CI 6.1 to 14.5; Figures from the ClinicalTrials.gov results section (first posted 2025-07-18), not from a publication · 95% CI 3.8 to 13.4
Source95% CI 2 to 4.2; Figures from the ClinicalTrials.gov results section (first posted 2025-07-18), not from a publication · 95% CI 1.8 to 2.1
SourceFigures from the ClinicalTrials.gov results section (first posted 2025-07-18), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall Survivalprimary | Irinotecan + Regorafenib (REGIRI) | 27 | 9 months | 1.18 (0.7 to 1.98) | 0.5334 | link |
| Regorafenib | 29 | 5.5 months | ||||
| Progression-free Survival (PFS) | Irinotecan + Regorafenib (REGIRI) | 33 | 3.6 months | 0.67 (0.4 to 1.11) | 0.1104 | link |
| Regorafenib | 33 | 1.9 months | ||||
| Number of Patients With an Objective Response Rate | Irinotecan + Regorafenib (REGIRI) | 27 | 2 participants | - | - | link |
| Regorafenib | 29 | 0 participants |
Shares FOLFIRI (5-FU, leucovorin, irinotecan), Anti-angiogenic therapy, Topoisomerase-I inhibitors (and ADC payloads), Colon cancer (adenocarcinoma of the colon) and the tag colorectal-deep-dive.
Shares Regorafenib, FOLFIRI (5-FU, leucovorin, irinotecan), Anti-angiogenic therapy, Topoisomerase-I inhibitors (and ADC payloads) and the tag colorectal-deep-dive.
Shares Regorafenib, Anti-angiogenic therapy, Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot) and the tag colorectal-deep-dive.
Shares Regorafenib, Anti-angiogenic therapy, Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot) and the tag colorectal-deep-dive.
Shares Regorafenib, Anti-angiogenic therapy, Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot) and the tag colorectal-deep-dive.
Shares Regorafenib, Anti-angiogenic therapy, Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot) and the tag colorectal-deep-dive.
Shares Regorafenib, Anti-angiogenic therapy, Colon cancer (adenocarcinoma of the colon), Colorectal cancer trials open today (registry snapshot) and the tag colorectal-deep-dive.
Shares FOLFIRI (5-FU, leucovorin, irinotecan), Anti-angiogenic therapy, Topoisomerase-I inhibitors (and ADC payloads), Colon cancer (adenocarcinoma of the colon) and the tag colorectal-deep-dive.