DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTehran University of Medical Sciences
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Drug-Eluting Embolic Bead
DrugA 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
DrugControl 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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: DEBIRI+ Chemotherapy +/- Targeted therapyExperimental treatment 1 intervention
Group B: Chemotherapy +/- Targeted therapyActive comparator 1 intervention
Trial outcomes
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).
Time frame
within 3 months after treatment initiationSecondary outcomes
1
Adverse event rate
Unfavorable and unintended signs and symptoms associated with the treatment.
Time frame
Within 1 year of treatment administrationSponsors and contacts
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Source ClinicalTrials.gov