Effectiveness of Irinotecan-Loaded Drug-Eluting Beads with Systemic Chemotherapy Compared to Chemotherapy Alone in Treating Unresectable or Borderline Resectable Colorectal Cancer Liver Metastases A Randomized Phase 3 Clinical Trial

What this Trial Is About

Researchers are evaluating treatment options for patients with unresectable or borderline resectable colorectal cancer that has spread to the liver. This randomized clinical trial compares the effects of irinotecan-loaded drug-eluting beads DEBIRI combined with systemic chemotherapy versus systemic chemotherapy alone in patients who have not previously received chemotherapy for their metastatic disease. The study aims to determine whether adding DEBIRI can increase the chance of making tumors operable within three months and to assess treatment tolerability, progression-free survival, and overall survival. Participants will be randomly assigned to one of two groups. The treatment group receives systemic chemotherapy on days 0 and 14, plus DEBIRI on days 7 and 21, with at least two doses of DEBIRI unless side effects prevent further treatment. The control group receives 4 cycles of systemic chemotherapy alone. Targeted therapies may be added in both groups based on tumor biology and patient condition. Imaging with MRI or CT scans will be used to monitor tumor response after 1 to 3 months. Throughout the study, patients undergo imaging reviewed by blinded radiologists to evaluate tumor shrinkage using RECIST criteria. The primary outcome is the proportion of patients whose tumors become operable within three months, assessed by a multidisciplinary team. Secondary outcomes include treatment side effects and survival rates. Participants will be followed closely for up to one year to monitor safety and disease progression.

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