Spots Global Cancer Trial Database for Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.

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Trial Identification

Brief Title: Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.

Official Title: Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University

Study ID: NCT05162898

Conditions

Recurrent Hepatocellular Cancer

Interventions

toripalimab

Lenvatinib

Radiofrequency ablation

Study Description

Brief Summary: This study is a multi-center, prospective, single-arm, open-design phase II clinical study, mainly to explore the clinical effectiveness and safety of radiofrequency ablation combined with anti-PD-1 antibody toripalimab and lenvatinib in patients with short-term recurrence of hepatocellular carcinoma.

Detailed Description: Primary endpoint: Recurrence-free survival time (RFS). Secondary endpoints: safety (incidence of adverse events); time to recurrence (TTR); time to local recurrence (TTLR); 12-month recurrence-free survival rate; overall survival (OS); 12 months and 24 Month overall survival rate. Treatment plan: Patients undergo radiofrequency ablation, 3-5 days after radiofrequency ablation, lenvatinib 12 mg (body weight ≥ 60 kg) or 8 mg (body weight \<60 kg) orally, once a day; toripalimab is a fixed dose of 240 mg, once every 3 weeks, intravenous infusion on the first day of each cycle, the infusion time is no less than 60 minutes.Combination therapy until tumor recurrence, disease progression, death or intolerable toxicity occurs.