Actively Recruiting
Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable Hepatocellular Carcinoma Patients With Cirrhotic Portal Hypertension
Led by Zhiyong Huang · Updated on 2025-08-15
60
Participants Needed
1
Research Sites
52 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
Researchers are investigating how splenectomy affects the success of combined targeted therapy and immunotherapy in patients with unresectable hepatocellular carcinoma (HCC) who also have cirrhotic portal hypertension. This study focuses on patients with poor liver function, severe splenic hyperfunction, and esophagogastric varices, conditions that may limit their ability to receive standard combination treatments. The trial also explores whether changes in the tumor immune environment after splenectomy influence immunotherapy outcomes. This single-arm, open-label observational study involves patients undergoing either open or laparoscopic splenectomy, with or without devascularization around the cardia. Two weeks after surgery, participants begin receiving intravenous infusions of the PD-1 monoclonal antibody Tislelizumab every three weeks. Three weeks post-surgery, they start daily oral targeted therapy with Lenvatinib, dosed based on body weight. Treatment continues until disease progression, unacceptable side effects, or other study-defined reasons to stop. Participants will have regular assessments including evaluation of tumor response six weeks after the first Tislelizumab dose, with longer-term monitoring of overall survival and progression-free survival. Researchers will track liver function, immune status, and safety throughout the study. The total involvement period extends up to around two years, allowing for detailed observation of treatment effects and patient outcomes.
CONDITIONS
Brief 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 under antiviral therapy
- ECOG performance status score of 0-1 without significant organ dysfunction
- Child-Pugh score of 5-7
- 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
- Important organ functions meeting specified liver and kidney parameter limits
- Ability to undergo local treatments such as TACE, HAIC, SIRT, SBRT, and ablation
- Willingness 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 cancers over 5 years or certain in situ cancers
- Presence or history of brain metastasis
- History of organ transplantation
- Major surgery in head, chest, or abdomen within past six months
- Child-Pugh class C liver function or significant ascites
- Marked thrombosis in portal venous system or extensive cancer thrombus in main portal vein
- Blood clotting abnormalities or bleeding history within two months prior to enrollment
- Active infection within 7 days after finishing systemic antibiotic therapy
- Active coronary artery disease, severe or unstable angina, or recent heart attack
- Recent thrombotic or embolic events within past 12 months
- NYHA class II or higher congestive heart failure
- HIV infection, AIDS, positive syphilis, or untreated active hepatitis
- Active or suspected autoimmune diseases except stable controlled conditions
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases
- Pregnant or breastfeeding women or females with positive pregnancy test prior to first dose
- Investigator judgment deeming subject inappropriate due to clinical or lab abnormalities or compliance
- Severe psychological or mental disorders
- Participation in another drug trial within past 4 weeks
- Other reasons judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo either open or laparoscopic splenectomy, with or without devascularization around the cardia.
1 surgical procedure visit followed by immediate post-operative care
Duration - From 2 weeks post-surgery until disease progression or discontinuation
Starting two weeks post-surgery, participants receive intravenous PD-1 monoclonal antibody (Tislelizumab) every three weeks and begin oral targeted therapy (Lenvatinib) three weeks post-surgery, continuing until disease progression, intolerable toxicity, or other reasons for stopping treatment.
Infusions every 3 weeks and daily oral medication
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Z
Zhiyong Huang
E
Erlei Zhang
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here