Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280313
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-20
Brief Title:
Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension
Sponsor:
Zhiyong Huang
Organization:
Tongji Hospital
Study Overview
Official Title:
Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This is a single-arm open-label observational study assessing the impact of splenectomy on the efficacy of combined targeted and immune therapy in patients with unresectable hepatocellular carcinoma accompanied by cirrhotic portal hypertension Eligible patients with unresectable hepatocellular carcinoma were enrolled in the trial and all participants underwent either open or laparoscopic splenectomy with or without devascularization around the cardia Starting two weeks post-surgery patients began intravenous infusion of PD-1 monoclonal antibody Tislelizumab at a dosage of 200mg every three weeks Three weeks post-surgery patients commenced oral administration of the targeted therapy Lenvatinib with a dosage based on body weight 8mg 60kg or 12mg 60kg once daily The use of Tislelizumab and Lenvatinib continued until the primary endpoint which was disease progression intolerable toxicity reactions or other criteria specified in the protocol for terminating the study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None