RecruitingNCT06280313

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


Sponsor

Zhiyong Huang

Enrollment

60 participants

Start Date

Mar 15, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether removing the spleen (splenectomy) in liver cancer (HCC) patients who also have portal hypertension (high blood pressure in the liver's blood vessels) can improve how well targeted therapy and immunotherapy work. Portal hypertension often causes an enlarged spleen and low blood counts that can limit treatment options. **You may be eligible if...** - You are between 18 and 75 years old - You have unresectable or recurrent liver cancer (HCC) - You have signs of portal hypertension, including an enlarged spleen and/or low white blood cell or platelet counts - You have hepatitis B that is being treated with antiviral therapy - Your liver function is relatively preserved (Child-Pugh 5-7) and ECOG 0-1 - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have another active cancer - You have severe heart, kidney, or autoimmune conditions - Your liver function is severely impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTSplenectomy+Targeted therapy+ Immunotherapy

Eligible patients with unresectable hepatocellular carcinoma accompanied by cirrhotic portal hypertension 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.


Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT06280313


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