Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
FOLFOX regimen: Leucovorin: 400 mg / m2 IV over 15 minutes on day 1 of each cycle. Fluorouracil (5-FU): 400mg / m2 IV bolus (15 min) followed by continuous IV infusion for 46 h of 2,400 mg / m2 on day 1 of each cycle. Oxaliplatin 85 mg / m2 IV over 120 minutes on cycle day 1
Anti-EGFR or Bevacizumab: In case of RAS wt colorectal cancer administer anti-EGFR together with FOLFOX6m, and in case of mutated RAS colorectal cancer administer Bevacizumab together with FOLFOX6m. Treatment administered following Summary of medicinal Product Characteristics (SmPC) approved indications.
LIVERPEARLS-Irinotecan: Chemoembolization of Irinotecan in 100 +/- 50 micron hydrogel microspheres. Irinotecan will be loaded at a dose of 100 mg. LIFEPEARLS® is a CE marked medical device consisting of microspheres for use in chemoembolization. This device allows the continuous release of irinotecan in liver tumors causing a specific necrosis. The penetration of irinotecan into the tumor tissue is deeper thanks to the microspheres, avoiding proximal occlusion of the vessels supplying the tumor.
Study 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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Clínic | Barcelona | Barcelona | |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona | |
| Hospital Parc Taulí | Sabadell | Barcelona | |
| H. Univ. Ramón y Cajal | Madrid | Madrid | |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | |
| Hospital Universitario La Paz | Madrid | Madrid | |
| Complejo Hospitalario de Navarra | Pamplona | Pamplona | |
| Hospital Universitari i Politècnic La Fe | Valencia | Valencia |
More Grupo Espanol Multidisciplinario del Cancer Digestivo trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04595266 on ClinicalTrials.gov ↗ ← All trials in Spain