Randomized, Multicenter Phase II Study of Monoclonal FOLFOX6m + mAb Alone or in Combination With Liver Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease Limited to the Liver With Poor Prognosis (LIVERPEARL)

NCT04595266 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Grupo Espanol Multidisciplinario del Cancer Digestivo
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	48
Start date	2021-06-29
Completion	2026-01

Conditions

• Colorectal Cancer Metastatic
• Liver Metastasis Colon Cancer

Interventions

• FOLFOX regimen
• Anti-EGFR or Bevacizumab
• LIVERPEARLS-Irinotecan

Primary outcomes

• Objective response rate (ORR) — Evaluated at 6 months after first investigation drug administration.
  The proportion of patients with tumor size reduction according to RECIST 1.1 criteria at 6 months

Countries

Spain