Actively Recruiting
Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension
Led by Zhiyong Huang · Updated on 2025-08-15
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
Z
Zhiyong Huang
Lead Sponsor
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years (inclusive)
- No prior systemic antitumor treatment or meeting criteria for splenectomy during treatment
- Clinical or pathological diagnosis of unresectable or recurrent hepatocellular carcinoma
- HBV-DNA less than 1*10^5 copies/ml and receiving antiviral therapy
- ECOG performance status score of 0-1 without significant organ dysfunction
- Child-Pugh score between 5 and 7
- Spleen thickness greater than 4.0 cm
- History of esophagogastric varices, red signs, or variceal bleeding with or without splenomegaly
- Splenomegaly with low white blood cell and platelet counts as specified
- Liver and kidney function within specified limits: ALT and AST ≤3 times ULN, total bilirubin ≤3 times ULN, INR ≤1.5 times ULN, prothrombin time ≤1.5 times ULN, creatinine ≤1.5 times ULN
- Able to undergo local treatments such as TACE, HAIC, SIRT, SBRT, and ablation
- Willing to provide informed consent
- Expected survival time of more than 3 months
You will not qualify if you...
- History of or current active malignancy (except cured malignancies over 5 years or certain in situ cancers)
- Central nervous system metastasis or history of brain metastasis
- History of organ transplantation
- Surgery in head, chest, or abdomen within past 6 months
- Child-Pugh class C liver function or significant ascites
- Severe thrombosis in portal venous system or extensive cancer thrombus in main portal vein
- Prolonged clotting times or bleeding tendency within 2 months prior to enrollment
- Active infection within 7 days after finishing antibiotic therapy
- Active coronary artery disease, recent angina or myocardial infarction within 12 months
- Recent thrombotic or embolic events within past 12 months
- NYHA class II or higher congestive heart failure
- HIV infection, positive syphilis, or untreated active hepatitis
- Active or suspected autoimmune disease (except stable conditions not needing systemic immunosuppressives)
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases
- Pregnant or breastfeeding women or positive pregnancy test prior to first dose with potential for pregnancy
- Investigator judgment deeming participant unsuitable due to clinical or compliance reasons
- Severe psychological or mental disorders
- Participation in another drug trial within past 4 weeks
- Other investigator-determined reasons for exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Z
Zhiyong Huang
CONTACT
E
Erlei Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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