Status:
RECRUITING
ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
HCC - Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- Age ≥18 years at the time of signing informed consent, regardless of gender.
- Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- BCLC Stage B or C.
- At least one measurable lesion per RECIST 1.1.
- ECOG score of 0-1.
- Child-Pugh liver function class A or B.
- Life expectancy ≥ 3 months.
- Adequate hematological and organ function.
Exclusion
- Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
- Pregnant or breastfeeding women.
- Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
- History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
- Presence of unhealed severe wounds, active ulcers, or untreated fractures.
- Active autoimmune disease or history of autoimmune disorders.
- Significant history of gastrointestinal diseases.
- Significant history of cardiovascular or cerebrovascular diseases.
Key Trial Info
Start Date :
February 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07157969
Start Date
February 19 2025
End Date
June 30 2027
Last Update
December 1 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China