NCT05738616

Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

Lenvatinib Combined With Transcatheter Arterial Chemoembolization and Camrelizumab Versus Lenvatinib Combined With Transcatheter Arterial Chemoembolization in Conversion Resection for Advanced Hepatocellular Carcinoma:A Randomized, Open-label, Parallel-controlled, Phase III Study(LEN-TAC Study)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Wen Tianfu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lenvatinib combined with TACE and Camrelizumab	Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE).

Timeline

• Start date: 2024-05-10
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2023-02-22
• Last updated: 2024-04-24

Locations

1 site across 1 country: China