Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 29, 2021

Primary Completion Date

January 15, 2024

Study Completion Date

January 31, 2026

Conditions
Colorectal Cancer MetastaticLiver Metastasis Colon Cancer
Interventions
DRUG

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"

BIOLOGICAL

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."

DRUG

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.

Trial Locations (8)

28044

H. Univ. Ramón y Cajal, Madrid

46026

Hospital Universitari i Politècnic La Fe, Valencia

Unknown

Hospital Clínic, Barcelona

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Parc Taulí, Sabadell

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Complejo Hospitalario de Navarra, Pamplona

All Listed Sponsors
lead

Grupo Espanol Multidisciplinario del Cancer Digestivo

OTHER