TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: A Multicenter Study

What this Trial Is About

Researchers are studying advanced hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT), a condition that leads to serious complications such as portal hypertension and gastrointestinal bleeding. This study focuses on preventing portal hypertension caused by PVTT to reduce the risk of bleeding, which is a leading cause of death in these patients, aside from tumor progression. The trial aims to add clinical evidence on combining several treatments for this severe disease. The study evaluates the combination of transjugular intrahepatic portosystemic shunt (TIPS) with systemic therapies including Lenvatinib and PD-1 inhibitors (Tislelizumab, Sintilimab, or Camrelizumab). TIPS is performed by puncturing the portal vein through the jugular vein and placing covered stents to reduce portal pressure. After TIPS, participants receive diuretics and a salt-limited diet. Lenvatinib dosing depends on body weight, and PD-1 inhibitors are given intravenously every three weeks. This combination treatment is explored as a first-line systemic therapy for advanced HCC with PVTT. Participants are involved in procedures to insert TIPS and receive regular systemic therapies. Researchers will monitor portal vein pressure, liver function tests, blood counts, and signs of gastrointestinal bleeding over six months. The main outcome measured is the rate of gastrointestinal hemorrhage within six months. Safety and treatment effects are carefully followed, with eligibility based on tumor characteristics, liver function, and overall health status. The study includes adults aged 18 to 75 years with confirmed primary HCC and specific types of PVTT, ensuring appropriate monitoring and follow-up during the trial.

TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT