NCT06555003 DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
| NCT ID | NCT06555003 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tehran University of Medical Sciences |
| Condition | Liver Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 116 participants in total. It began in 2025-01-20 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Ali Jafarian, MD
PRINCIPAL INVESTIGATOR
Tehran University of Medical Sciences, Tehran, Iran
Frequently Asked Questions
Who can join the NCT06555003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06555003 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 116 participants.
Is NCT06555003 currently recruiting?
Yes, NCT06555003 is actively recruiting participants. Contact the research team at Mirzasadeghianahita@gmail.com for enrollment information.
Where is the NCT06555003 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT06555003 clinical trial?
NCT06555003 is sponsored by Tehran University of Medical Sciences. The principal investigator is Ali Jafarian, MD at Tehran University of Medical Sciences, Tehran, Iran. The trial plans to enroll 116 participants.