Comparing Drug-Eluting Bead and Conventional Chemoembolization for Advanced Liver Cancer After a TIPS Procedure A Phase 3 Randomized Study

What this Trial Is About

Researchers are studying patients with hepatocellular carcinoma HCC that exceeds the Milan criteria and have previously undergone a Transjugular Intrahepatic Portosystemic Shunt TIPS procedure. The trial compares two treatments Drug-Eluting Bead Transarterial Chemoembolization DEB-TACE and Conventional Transarterial Chemoembolization cTACE. This Phase 3, open-label, randomized controlled study aims to evaluate which treatment improves overall survival and other outcomes in this specific group of patients, as current treatment options after TIPS are limited and unclear. Participants will be randomly assigned to receive either DEB-TACE or cTACE. DEB-TACE uses drug-loaded microspheres to deliver chemotherapy directly to tumor arteries, while cTACE uses chemotherapy with ethiodized oil followed by embolization with gelatin sponge particles if needed. Both procedures involve superselective catheterization of tumor-feeding arteries by experienced radiologists. Treatments may be repeated every 6-8 weeks based on imaging results and liver function, stopping if disease progresses or liver impairment persists. During the 24-month treatment and follow-up phase, participants will undergo regular imaging assessments and monitoring to evaluate tumor response, disease progression, and side effects. Researchers will measure overall survival as the primary outcome, along with progression-free survival, tumor response, adverse events, and quality of life. The study will last approximately 48 months in total, including recruitment and follow-up, aiming to provide strong evidence for the best treatment approach in this patient population.

DEB-TACE vs cTACE in HCC After TIPS