Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Non-commercial, prospective, randomized, multicenter, national, phase II, open-label
comparative clinical trial.
The patients will be randomized in a 1: 1 ratio in two arms:
Control arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab Experimental arm. Systemic
chemotherapy with FOLFOX6m + monoclonal Ab + Intra-arterial liver chemotherapy with
LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded
with 100 mg of irinotecan in both liver lobes) cycles 2 and 4.
The main objective is to evaluate the radiological objective response rate according to the
RECIST version 1.1 criteria at 6 months. Secondary objectives include: Evaluate overall
survival, progression-free survival (PFS), safety profile, hepatic PFS, R0 liver surgery
rate.
Phase:
Phase 2
Details
Lead Sponsor:
Grupo Espanol Multidisciplinario del Cancer Digestivo