NCT05162898

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

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Hepatocellular Cancer

Interventions

Type	Name	Description
DRUG	toripalimab	240mg,ivgtt, every three weeks as a cycle, the first day of each cycle.
DRUG	Lenvatinib	12mg (weight ≥60kg) or 8mg (weight \<60kg) orally, once a day
DEVICE	Radiofrequency ablation	ultrasound-guided percutaneous radiofrequency ablation of recurrent hepatocellular carcinoma

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2021-12-17
• Last updated: 2022-01-27