Combining DEBIRI with chemotherapy for colorectal cancer liver metastases
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
This study is testing if adding a special treatment called DEBIRI to regular chemotherapy can help patients with colorectal cancer that has spread to the liver feel better and possibly have surgery later.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tehran University of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tehran, Tehran Province) |
| Trial ID | NCT06555003 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining irinotecan loaded drug-eluting beads (DEBIRI) with standard systemic chemotherapy in patients with unresectable or borderline resectable liver metastases from colorectal cancer. A total of 116 chemotherapy-naïve patients will be randomly assigned to receive either the combination treatment or chemotherapy alone. The study will assess treatment response using imaging techniques and evaluate the feasibility of secondary tumor resection after treatment. Stratified randomization will control for confounding factors related to tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable or borderline resectable colorectal cancer liver metastases who have not received prior chemotherapy.
Not a fit: Patients who are candidates for curative surgery or have extensive liver involvement, brain metastases, or cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with colorectal cancer liver metastases.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * unresectable/borderline resectable colorectal cancer liver metastases, chemotherapy-naïve for metastatic disease, Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less adequate hematologic, hepatic, and renal function ( absolute neutrophil count ≥ 1.5 × 10\^9/L, platelet ≥ 75 ×10\^9/L, international normalized ratio ≤ 1.3, Total bilirubin ≤ 2.0 mg/dL, aspartate aminotransferase and alanine aminotransferase ≤ 5 × the upper limit of normal (ULN), Albumin ≥ 2.5 g/dL, Creatinine ≤ 2.0 mg/dL) Exclusion Criteria: * candidates for curative surgery without the need for neoadjuvant therapy, Liver involvement of ≥ 70%, brain metastases or Peritoneal carcinomatosis, cirrhosis, presence or History of an allergic reaction to any of the study drugs Chronic viral hepatitis B or C
Where this trial is running
Tehran, Tehran Province
- Imam khomeini hospital complex — Tehran, Tehran Province, Iran (Recruiting)
Study contacts
- Principal investigator: Ali Jafarian, MD — Tehran University of Medical Sciences, Tehran, Iran
- Study coordinator: Anahita Mirzasadeghi, MD
- Email: Mirzasadeghianahita@gmail.com
- Phone: +989123193830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.