Actively Recruiting
DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
Led by Tehran University of Medical Sciences · Updated on 2025-04-23
116
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with unresectable or borderline resectable colorectal cancer liver metastases
- No prior chemotherapy for metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate blood counts and liver function: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L, INR ≤ 1.3
- Total bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 5 times the upper limit of normal
- Albumin ≥ 2.5 g/dL
- Creatinine ≤ 2.0 mg/dL
You will not qualify if you...
- Eligible for curative surgery without needing neoadjuvant therapy
- Liver involvement of 70% or more
- Presence of brain metastases or peritoneal carcinomatosis
- Liver cirrhosis
- History or presence of allergic reaction to any study drugs
- Chronic viral hepatitis B or C
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Imam khomeini hospital complex
Tehran, Tehran Province, Iran, 1419733141
Actively Recruiting
Research Team
A
Anahita Mirzasadeghi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here