DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases

NCT06555003 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 72101-246-1-1403
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Neoplasm; Colorectal Cancer Metastatic

Keywords

irinotecan loaded drug-eluting beads TACE (DEBIRI-TACE); colorectal liver metastases; survival; irinotecan; chemoembolization

Outcome Measures

Primary Outcomes (1)

• Conversion to resectability: The proportion of patients who were initially deemed unresectable but, after undergoing specific intervention (Based on study arm) are reassessed for tumor shrinkage and found to be candidates for surgical resection.

  The feasibility of secondary tumor resection after receiving treatment, based on follow up imaging and tumor downsizing, will be discussed in multidisciplinary meeting (including surgeons, radiologists and oncologists).

  within 3 months after treatment initiation

Secondary Outcomes (1)

• Adverse event rate

  Within 1 year of treatment administration

Study Arms (2)

DEBIRI+ Chemotherapy +/- Targeted therapy

EXPERIMENTAL

Patients will receive systemic chemotherapy on day 0 and 14 and DEBIRI on day 7 and 21.

Drug: Drug-Eluting Embolic Bead

Chemotherapy +/- Targeted therapy

ACTIVE COMPARATOR

Patients will receive 4 cycles of systemic chemotherapy.

Drug: Chemotherapy drug

Interventions

Drug-Eluting Embolic Bead DRUG

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.

Also known as: Irinotecan-loaded drug-eluting beads (DEBIRI) plus systemic chemotherapy +/- targeted therapy

DEBIRI+ Chemotherapy +/- Targeted therapy

Chemotherapy drug 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.

Also known as: Systemic chemotherapy +/- targeted therapy

Chemotherapy +/- Targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam khomeini hospital complex

Tehran, Tehran Province, 1419733141, Iran

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Ali Jafarian, MD

  Tehran University of Medical Sciences, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Mirzasadeghi, MD

CONTACT

+989123193830; Mirzasadeghianahita@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Surgery

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 15, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)