Combining DEBIRI with chemotherapy for colorectal cancer liver metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.