Postoperative chemotherapy reintroduction in good responders after colorectal liver metastases resection: A French randomized phase III trial - IRIMAD.

Authors

Camélia Labiad, Antoine Brouquet, Jean-Baptiste Bachet, Solafah Abdalla, Jérémie Lefèvre, Eric Vicaut, Stéphane Benoist, on behalf the FRENCH study group

Published in

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. Oct 08, 2026. Epub Oct 08, 2026.

Abstract

Most patients who develop metachronous colorectal liver metastases (CRLM) have previously received adjuvant FOLFOX for stage III primary cancer. Perioperative FOLFOX is often contraindicated due to persistent neuropathy or suspected oxaliplatin resistance, leading most of these patients to receive preoperative FOLFIRI±a VEGF/EGFR-targeting biologic. The benefit of reintroducing FOLFIRI as adjuvant treatment in good responders has never been evaluated.
This is a multicentre, open-label, randomised, two-arm, phase III superiority trial. Eligible patients who underwent curative (R0/R1) resection of fewer than 10 metachronous CRLM showing objective response after 2-8 cycles of preoperative FOLFIRI will be randomised to postoperative FOLFIRI reintroduction (experimental arm, 4-10 cycles to reach a total of 12 perioperative cycles) or no postoperative treatment (control arm). The primary endpoint is 3-year disease-free survival. Secondary endpoints include overall survival, liver-free survival, extra-hepatic recurrence rate, compliance, quality of life, and treatment-related toxicity. The required sample size is 254 patients (127 per arm).
Currently, patients treated with preoperative FOLFIRI receive no adjuvant chemotherapy, as trials failed to show benefit in unselected populations. Demonstrating efficacy of adjuvant FOLFIRI in good responders would validate the concept of tailored postoperative treatment based on chemotherapy response.
ClinicalTrials.gov NCT06501482 (07/2024). https://clinicaltrials.gov/study/NCT06501482.

PMID:
42850173
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.