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

NCT04595266 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: GEMCAD-18022020-003795-40
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Colorectal Cancer Metastatic; Liver Metastasis Colon Cancer

Keywords

Colorectal cancer; Chemoembolization; LIVERPEARLS-Irinotecan; Liver metastasis

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The proportion of patients with tumor size reduction according to RECIST 1.1 criteria at 6 months

  Evaluated at 6 months after first investigation drug administration.

Secondary Outcomes (5)

• Overall Survival (OS)

  Through study completion, average 2 years

• Progression free survival

  Through study completion, average 2 years. Evaluated during a total of 2 years (estimated) by CT scan or MR every 12 weeks

• Frequency of adverse events

  Through study completion, average 2 years

• Hepatic Progression free survival

  Through study completion, average 2 years. Evaluated during a total of 2 years (estimated) by CT scan or MR every 12 weeks

• Proportion of patients with liver surgery

  Through study completion, average 2 years.

Study Arms (2)

Control

ACTIVE COMPARATOR

Systemic chemotherapy with FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab).

Drug: FOLFOX regimen; Biological: Anti-EGFR or Bevacizumab

Experimental

EXPERIMENTAL

Systemic chemotherapy with FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab) + 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.

Drug: FOLFOX regimen; Biological: Anti-EGFR or Bevacizumab; Drug: LIVERPEARLS-Irinotecan

Interventions

FOLFOX regimen DRUG

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

Also known as: Leucovorin/Fluorouracil/Oxaliplatin

Control; Experimental

Anti-EGFR or Bevacizumab BIOLOGICAL

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.

Also known as: monoclonal antibody anti EGFR (RASwt) or Bevacizumab (RASmut)

Control; Experimental

LIVERPEARLS-Irinotecan DRUG

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.

Also known as: Chemoembolization of Irinotecan in hydrogel microspheres

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years.
• Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,\> 3 lesions and / or size\> 5 cm. Patients with a diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable.
• Measurable disease following RECIST version 1.1 criteria
• Adequate bone marrow function, according to:
• Platelet count ≥ 100 x 109 / L
• Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L
• Adequate liver function, according to:
• Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
• Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases
• Adequate renal function, with creatinine levels \<1.5 mg / dL. Blood Ureic Nitrogen (BUN)\> 50 ml / min.
• Albumin\> 3.0 g / dL
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Patients capable of understanding the information and giving their written informed consent to participate in the study
• Women of childbearing potential must commit to sexual abstinence or use of barrier contraceptive methods during the study and must have a negative pregnancy test.

You may not qualify if:

• Previous chemotherapy treatment for metastatic colorectal cancer
• History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
• Altered coagulation (Quick\> 50%)
• Patients with active infectious processes
• Patients with any of the contraindications specified in the technical data sheet of the study drug or with allergies to some of the drugs used
• Pregnant or lactating patients
• Portal thrombosis
• Severe portal hypertension
• Extrahepatic metastases

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead

Study Sites (8)

Hospital Clínic

Barcelona, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Location

H. Univ. Ramón y Cajal

Madrid, Madrid, 28044, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Pamplona, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol; Leucovorin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Estela Pineda, M.D

  Hospital Clinic of Barcelona

  STUDY CHAIR

• David Páez, M.D., Ph.D.

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1: 1 ratio in the 2 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.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 20, 2020
• Study Start: June 29, 2021
• Primary Completion: January 15, 2024
• Study Completion: January 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

ES (8)