Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study

Summary

Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy. Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic. Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers. The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.

Timeline

Start

2013-05

Primary completion

2017-12

Completion

2019-01

Outcome

Missed primary endpoint

paper Front-line DEBIRI + mFOLFOX6 should not be recommended as the hypothesised 9-month PFS was not met. PMID 32507854 ↗

Publications

• Results Pernot S, Pellerin O, Artru P, Monterymard C, Smith D, Raoul JL, De La Fouchardiere C, Dahan L, Guimbaud R, Sefrioui D, Jouve JL, Lepage C, Tougeron D, Taieb J; for FFCD1201-DEBIRI investigators/Collaborators. Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study. Br J Cancer. 2020 Aug;123(4):518-524. doi: 10.1038/s41416-020-0917-4. Epub 2020 Jun 8.

Drugs

Indications