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

Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population.

NCT Number	NCT06280313
Lead Sponsor	Zhiyong Huang Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhongnan Hospital, Renmin Hospital of Wuhan University, Taihe Hospital, Hubei Cancer Hospital, Xiangyang Central Hospital, Wuhan Central Hospital, Yichang Third Renmin Hospital
Conditions	Unresectable Hepatocellular Carcinoma
Enrollment	60 participants
Start Date	2024-03-15
Primary Completion	2027-03-15 (estimated)
Study Completion	2028-03-15 (estimated)
Updated on ClinicalTrials.gov	2025-08-15