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
Conditions
Interventions
Intervention 1: Intervention group: For the intervention group, a minimum of 2 sessions of DEBIRI treatment and 2 to 4 cycles of systemic chemotherapy are administered (based on tumor size, bilobar or
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion to resectability. Timepoint: Tumor downsizing will be evaluated within three months of treatment initiation. Method of measurement: Downsizing of the liver tumors will be assessed by RECIST criteria. The feasibility of secondary tumor resection will be reassessed at a three-month follow-up multidisciplinary team (MDT) meeting, guided by established clinical guidelines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate. Timepoint: upon treatment initiation till last follow up. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAnahita Mirzasadeghi
Tehran University of Medical Sciences
Outcome results
None listed