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

Trial ID: NCT04595266

Interventional - Phase 2 - Active, not recruiting

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

Interventions

• FOLFOX regimen
• Anti-EGFR or Bevacizumab
• LIVERPEARLS-Irinotecan

Eligibility

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

Sponsor

Grupo Espanol Multidisciplinario del Cancer Digestivo

Source: ClinicalTrials.gov

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