TACE Combined With Penpulimab and Anlotinib for Advanced HCC

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib

• Registration Number: NCT05344924
• Lead Sponsor: Zhongda Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Study Start: 2022-10-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29
• Primary Completion: 2023-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort I（TACE-A-A Cohort）	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.
Cohort II (A-A Cohort)	TACE+penpulimab+anlotinib vs. penpulimab+anlotinib	Patients will receive 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.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years	Time from initiation of either combination therapy to tumor progression according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	2 years	The proportion of patients with complete response (CR) and partial response (PR) according to the mRECIST criteria.
Overall survival (OS)	up to 5 years	The time from initiation of either regimen of combination therapy to all-cause death.
Adverse effects	2 years	Adverse event (AE)，treatment emergent adverse event(TEAE)，serious adverse event (SAE)

Trial Locations

Locations (1)

Zhongda Hospital Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China