Study of bTAE-HAIC with Lenvatinib and Sintilimab for Treating Infiltrative Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combination treatment involving blank-microsphere transcatheter arterial embolization bTAE and hepatic arterial infusion chemotherapy HAIC with oxaliplatin, 5-fluorouracil, and leucovorin, together with the drugs Lenvatinib and Sintilimab, for patients diagnosed with infiltrative hepatocellular carcinoma. This prospective, single-arm study aims to provide new insights since no prior study has assessed this specific combination. The trial is sponsored by Sun Yat-sen University. The treatment involves a bTAE procedure where a microcatheter is carefully inserted into the artery feeding the tumor, followed by the use of blank microspheres sized according to the tumor blood supply vessels. Afterward, chemotherapy drugs oxaliplatin, fluorouracil, and leucovorin are infused via the hepatic artery every four weeks. Participants take Lenvatinib orally once daily and receive Sintilimab infusions every three weeks. This combined treatment is studied to assess its impact on tumor response and patient survival. Participants will undergo regular assessments including imaging and laboratory tests to monitor tumor response and safety. The primary outcome measured is the objective response rate at six months. Secondary outcomes include progression-free survival at six months and overall survival at twelve months. The study will monitor participants throughout the treatment period, including evaluations of liver function, blood counts, and overall health status, with the total participation duration varying by individual.

bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma