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Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease
Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2021-06-29
Completion Date
2026-01
Last Updated
2025-09-29
Healthy Volunteers
No
Interventions
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.
Locations (8)
Hospital Clínic
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
H. Univ. Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Pamplona, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain