Study of Splenectomy Combined with Targeted and Immunotherapy in Patients with Unresectable Liver Cancer and Cirrhosis-Related Portal Hypertension

What this Trial Is About

Researchers are investigating how splenectomy affects the success of combined targeted therapy and immunotherapy in patients with unresectable hepatocellular carcinoma HCC who also have cirrhotic portal hypertension. This study focuses on patients with poor liver function, severe splenic hyperfunction, and esophagogastric varices, conditions that may limit their ability to receive standard combination treatments. The trial also explores whether changes in the tumor immune environment after splenectomy influence immunotherapy outcomes. This single-arm, open-label observational study involves patients undergoing either open or laparoscopic splenectomy, with or without devascularization around the cardia. Two weeks after surgery, participants begin receiving intravenous infusions of the PD-1 monoclonal antibody Tislelizumab every three weeks. Three weeks post-surgery, they start daily oral targeted therapy with Lenvatinib, dosed based on body weight. Treatment continues until disease progression, unacceptable side effects, or other study-defined reasons to stop. Participants will have regular assessments including evaluation of tumor response six weeks after the first Tislelizumab dose, with longer-term monitoring of overall survival and progression-free survival. Researchers will track liver function, immune status, and safety throughout the study. The total involvement period extends up to around two years, allowing for detailed observation of treatment effects and patient outcomes.

Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension