drugset / Trial / NCT06555003

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

NCT06555003 ↗

Phase 3 Recruiting 116 enrolled Tehran University of Medical Sciences
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2025-01-20
Primary completion
2027-10
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 100 mg Other
Comparator Bevacizumab Monoclonal antibody — —
Comparator Pembrolizumab Monoclonal antibody — —