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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
200 mg intravenously every three weeks
1200 mg intravenously every three weeks
15mg/kg intravenously every three weeks
200 mg intravenously every three weeks
250mg once daily
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
200 mg intravenously every three weeks
200 mg intravenously every three weeks
Peking Union Medical College Hospital
Beijing, China
RECRUITINGORR, objective response rate
Time frame: 12 months after the last subject is enrolled
PFS, progression free survival
Time frame: 12 months after the last subject is enrolled
OS, overall survival
Time frame: 12 months after the last subject is enrolled
DCR, disease control rate
Time frame: 12 months after the last subject is enrolled
DoR, duration of response
Time frame: 12 months after the last subject is enrolled
Adverse events (AE)
Time frame: 12 months after the last subject is enrolled
Serious adverse events (SAE)
Time frame: 12 months after the last subject is enrolled
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