A Multi-center, Randomized, Controlled, Open-label Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With Traditional Transarterial Chemoembolization (TACE) in Intermediate-Stage Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of transarterial tirapazamine embolization (TATE) compared to conventional transarterial chemoembolization (cTACE) for patients with intermediate-stage hepatocellular carcinoma (HCC), a type of liver cancer. This phase II/III clinical trial aims to determine if TATE offers potential benefits over the current standard treatment, providing important insights for future care. The study is sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd and involves random assignment of participants to treatment groups. Participants will be randomly assigned to receive one of two treatments. The TATE group will receive a fixed dose of 35 mg tirapazamine injected into the artery feeding the tumor, followed by embolization using iodized oil, gelatin sponge, and contrast agent. The cTACE group will be treated with a mixture of iodized oil and 50 mg epirubicin, followed by embolization with gelatin sponge and contrast agent. Both treatments aim to block blood flow to the tumor and deliver therapy directly to the liver. The treatments are given as procedures involving catheter-based arterial injections. During the study, participants will be monitored for up to 36 months to assess progression-free survival as the primary outcome. Secondary outcomes include complete response rate, objective response rate, duration of complete response, and overall survival. Researchers will perform regular evaluations to track tumor response and patient health. Safety and treatment effects will be closely observed throughout the study period, ensuring participant well-being and thorough data collection.

A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.