At a glance
ClinicalIndex Comparison RecordPhase 3Active· 377 enrolled
Drug / intervention
Regorafenib +1 moredrug
Likely dose
Regorafenib 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Institut du Cancer de Montpellier - Val d'Aurelle·interventional·Posted Feb 4, 2019·Updated Nov 21, 2025
In Brief
A Phase 3 clinical trial evaluating Regorafenib and Irinotecan for Metastatic Colorectal Cancer (mCRC). Active but no longer recruiting, targeting 377 participants across 11 sites.
Detailed Summary
Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and Lonsurf) no longer have treatment options available while maintaining a good performance status which would allow them to receive a new treatment
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer (mCRC)
CountriesFrance
Collaborators--
Timeline
Phase 3Active
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionSep 2024
TodayJul 2026
Study CompletionSep 2026
First PostedFeb 4, 2019
Enrollment StartMar 28, 2019
Primary CompletionSep 4, 2024
Study CompletionSep 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.4 years ago
Interventions
Regorafenibdrug
regorafenib tab 40 mg i.e 160 mg/day
Irinotecandrug
irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more