DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases

A total of 116 patients who meet the inclusion criteria and are chemotherapy-naïve for their metastatic disease, will be randomly assigned to either the treatment group (DEBIRI plus systemic chemotherapy) or the control group (systemic chemotherapy alone). After 4 cycles of chemotherapy and 2 cycles of DEBIRI, patient reassessment to evaluate treatment response, based on RECIST criteria, will be performed using MRI or CT scan within 1-3 months of treatment initiation. The feasibility of secondary tumor resection, as primary endpoint, will be reassessed at a three-month follow-up multidisciplinary team (MDT) meeting, guided by established clinical guidelines.

NCT Number	NCT06555003
Lead Sponsor	Tehran University of Medical Sciences
Conditions	Liver Neoplasm, Colorectal Cancer Metastatic
Enrollment	116 participants
Start Date	2025-01-20
Primary Completion	2027-10 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-23