NCT05344924

TACE Combined With Penpulimab and Anlotinib for Advanced HCC

Transarterial Chemoembolization Combined With Penpulimab and Anlotinib for Advanced Hepatocellular Carcinoma：A Nationwide Multicenter Prospective Real-world Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 109 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multicenter, dual-cohort, prospective real-world study is to explore the efficacy and safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients.

Detailed description

The efficacy and safety of transarterial chemoembolization (TACE) combined with penpulimab and anlotinib in the treatment of advanced hepatocellular carcinoma (HCC) remain unknown. This is a multicenter, dual-cohort, prospective real-world study with patients receiving normal clinical care. Patients in cohort I will receive TACE combined with penpulimab and anlotinib (TACE-A-A Cohort), and patients in cohort II will just receive penpulimab and anlotinib (A-A Cohort). The primary endpoints of this study are the efficacy of penpulimab and anlotinib combined with or without TACE in advanced HCC patients. While the secondary endpoints include the safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients. The results will provide further evidence for the clinical practice and the design of future trials.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	TACE+penpulimab+anlotinib vs. penpulimab+anlotinib	Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-03-31
• Completion: 2024-03-31
• First posted: 2022-04-25
• Last updated: 2022-12-29

Locations

1 site across 1 country: China