Actively Recruiting
ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
Led by Peking Union Medical College Hospital · Updated on 2025-12-01
300
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
CONDITIONS
Official Title
ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate and provide written informed consent, show good compliance, and cooperate with follow-up.
- Age 18 years or older at the time of consent, any gender.
- Confirmed diagnosis of hepatocellular carcinoma by imaging, histology, or cytology.
- BCLC Stage B or C liver cancer.
- At least one measurable tumor lesion by RECIST 1.1 criteria.
- ECOG performance status score of 0 or 1.
- Child-Pugh liver function class A or B.
- Expected life expectancy of at least 3 months.
- Adequate blood counts and organ function.
You will not qualify if you...
- Eligible for surgical cure or have had radical surgery without measurable lesions, or history of/planned liver transplant.
- Pregnant or breastfeeding women.
- Known allergy or intolerance to PD-1/PD-L1 monoclonal antibodies.
- Received local-regional therapy within 4 weeks before starting study drug.
- History of other cancers within 5 years except hepatocellular carcinoma.
- Unhealed severe wounds, active ulcers, or untreated fractures.
- Active or history of autoimmune diseases.
- Significant gastrointestinal diseases.
- Significant cardiovascular or cerebrovascular diseases.
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
S
Shi Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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