protocolSection identificationModule nctId: NCT06280313, orgStudyIdInfo id: uHCC-STI-TJ01, briefTitle: Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2028-03-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Zhiyong Huang, class: OTHER, collaborators name: Wuhan Union Hospital, China, collaborators name: Wuhan University, collaborators name: Renmin Hospital of Wuhan University, collaborators name: Taihe Hospital, collaborators name: Hubei Cancer Hospital, collaborators name: Xiangyang Central Hospital, collaborators name: Wuhan Central Hospital, collaborators name: Yichang Third Renmin Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Unresectable Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Splenectomy+Targeted therapy+ Immunotherapy, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Zhiyong Huang, role: CONTACT, phone: 86-13995507729, email: Zyhuang126@126.com, contacts name: Erlei Zhang, role: CONTACT, email: baiyu19861104@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False