This study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (the combination antibody) combined with SBRT and Lenvatinib in the perioperative treatment of patients with potentially resectable intermediate-stage hepatocellular carcinoma.. The objective is to explore potential survival benefits for this population and provide patients with more effective treatment options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Iparomlimab/Tuvonralimab: Intravenous infusion of 7.5 mg/kg repeated every 21 days as one cycle. Administration for 2-3 cycles before sugery and continuously for one year after surgery. Lenvatinib: orally at a dose of 8 mg once daily (for patients with body weight \<60 kg) or 12 mg once daily (for patients with body weight ≥60 kg), and taken continuously for one year after surgery. Stereotactic body radiation therapy: 40-45 Gy/5F, once daily, 1-2 weeks before Iparomlimab/Tuvonralimab. Surgery will be performed within 4-6 weeks after the last dose of conversion therapy, with a maximum of 12 weeks.
Tianjin medical university institute & hospital
Tianjin, China
RECRUITINGIncidence of TEAEs
including adverse events and their severity (classified according to CTCAE v5.0), frequency of occurrence, etc.
Time frame: From date of randomization until the occurrence of adverse events assessed up to 24 months
Rate of R0 Resection
The proportion of patients in whom the tumor is completely removed with no residual microscopic disease (negative surgical margins).
Time frame: From date of randomization until the completion of operation assessed about 6 months
Event-Free Survival
The time from randomization to the occurrence of any predefined event, which may include disease progression, recurrence, death, or treatment failure.
Time frame: From date of randomization until disease progression, recurrence, death, or treatment failure assessed up to 24 months
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