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

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
• Treatments: Bevacizumab; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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:

1. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study

2. Platelet count ≥ 100 x 109 / L

3. Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L

• Adequate liver function, according to:

1. Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)

2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.

3. Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases

4. Adequate renal function, with creatinine levels <1.5 mg / dL. Blood Ureic Nitrogen (BUN)> 50 ml / min.

5. 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.

Exclusion Criteria:

• Extension of the disease> 50% of the liver parenchyma (evaluated by CT performed within the month prior to inclusion)

• Previous chemotherapy treatment for metastatic colorectal cancer

• Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before inclusion in the trial), myocardial infarction (≤ 6 months before inclusion in the trial), unstable angina, uncontrolled hypertension, congestive heart failure of New York Heart Association (NYHA) grade II or higher or severe cardiac arrhythmia.

• 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