Clinical Research Directory
Browse clinical research sites, groups, and studies.
DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
Sponsor: Tehran University of Medical Sciences
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.
Official title: Comparative Analysis of the Efficacy of Irinotecan-loaded Drug-eluting Beads (DEBIRI) in Combination With Systemic Chemotherapy Versus Chemotherapy Alone in Unresectable Colorectal Cancer Liver Metastases: a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2025-01-20
Completion Date
2027-12
Last Updated
2025-04-23
Healthy Volunteers
No
Interventions
Drug-Eluting Embolic Bead
A minimum of 2 sessions of DEBIRI treatment and 2-4 cycles of systemic chemotherapy are administered (based on tumor size, bilobar or unilobar involvement of the liver, treatment response rate, treatment tolerance, occurrence of side effects, and liver function). Prior to performing DEBIRI, initial angiography is done via the femoral or axillary artery to determine the anatomy of the right and left hepatic arteries as well as the arteries supplying the tumor. Subsequently, a vial of irinotecan (100 mg) eluted with a vial of beads(hepaSphere 25mg) is injected into the blood vessels feeding the tumor. The intervention will be repeated to deliver 200 mg of irinotecan intravascularly to the liver mass. A 14-day interval between the procedures is established to minimize side effects. Targeted therapy administration for each treatment group based on oncologist's decision and will be tailored to the tumor characteristics and the patient's clinical status as explained in control arm.
Chemotherapy drug
Control group will receive 2-4 cycles of systemic chemotherapy based on functional status of the patient, adverse event rate and treatment tolerance, tumor size and characteristics. Targeted therapy administration for each treatment group in based on oncologist's decision and will be tailored to the tumor characteristics and the patient's clinical status (e.g., administration of Pembrolizumab for patients with high rosatellite instability (MSI-H) or Bevacizumab for tumors harboring KRAS mutations). Due to the targeted nature of these therapies, they can not be administered to all participants of the trial, while It is not ethically justifiable to withhold targeted therapies from patients who are candidates for these treatments based on their tumor characteristics and deprive them of potentially life-extending options.
Locations (1)
Imam khomeini hospital complex
Tehran, Tehran Province, Iran