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

Launched by TEHRAN UNIVERSITY OF MEDICAL SCIENCES · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with liver tumors caused by colorectal cancer that cannot be surgically removed. The trial will compare two groups of patients: one group will receive a combination of a treatment called DEBIRI along with standard chemotherapy, while the other group will receive only the standard chemotherapy. The goal is to see if adding DEBIRI improves treatment outcomes and makes it possible for patients to undergo surgery in the future.

To be eligible for this trial, patients should have liver tumors that are either unresectable (cannot be removed) or borderline resectable, and they should not have received any previous chemotherapy for this type of cancer. Participants will be closely monitored during the trial, undergoing scans to assess how well the treatment is working after a series of chemotherapy sessions. This trial is not yet recruiting participants but aims to provide valuable insights into improving treatment options for those with advanced colorectal cancer affecting the liver.

Gender

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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