Efficacy of DEBIRI in colorectal cancer liver metastases

Phase 3

Recruiting

• Conditions: Condition 1: Colorectal cancer liver metastases. Condition 2: Colorectal cancer liver metastases. Condition 3: Colorectal cancer liver metastases.; Secondary malignant neoplasm of liver and intrahepatic bile duct; Malignant neoplasm of colon; Malignant neoplasm of rectum; C78.7

• Registration Number: IRCT20240627062267N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Patients with histologically proven, unresectable or borderline resectable liver metastases from colorectal origin, who are 18 years or older and
Patients who are chemotherapy-naïve for their metastatic disease
Metastases burden must be exclusively or predominantly limited to the liver.
Adequate hematologic, hepatic, and renal function ( ANC = 1.5 × 10^9/L•PLT = 75 × 10^9/L•INR = 1.3•Total bilirubin = 2.0 mg/dL•AST and ALT = ×5 the upper limit of normal (ULN)•Albumin = 2.5 g/dL•Creatinine = 2.0 mg/dL)
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion Criteria

Patients who are candidates for curative surgery without the need for neoadjuvant therapy
Liver involvement of = 70%
Presence of brain metastases
Peritoneal carcinomatosis
Presence or History of an allergic reaction to any of the study drugs
Chronic viral hepatitis B or C
Cirrhosis
Pregnancy (based on elevated serum or urine B-HCG level)
Breastfeeding
Patient’s refusal to participate in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified