Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease
Ontology highlight
ABSTRACT: 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.
DISEASE(S): Neoplasm Metastasis,Liver Metastasis Colon Cancer,Colorectal Cancer,Colorectal Cancer Metastatic,Colorectal Neoplasms
PROVIDER: 2355124 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
ACCESS DATA