NCT01839877

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer With Non Resectable Hepatic Metastasis

Interventions

Type	Name	Description
DRUG	HIA DEBIRI + systemic FOLFOX

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-12-01
• Completion: 2019-01-01
• First posted: 2013-04-25
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

9 sites across 1 country: France