TACE Combined With Penpulimab and Anlotinib for Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344924
• Other study ID #: CHANCE 2205
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 12, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2022
• Source: Zhongda Hospital
• Contact: Hai-Dong Zhu, MD
• Phone: 86-25-83262224
• Email: zhuhaidong9509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• Pathologically or clinically diagnosed HCC patients;

• Age of 18-80;

• Barcelona Clinic Liver Cancer (BCLC) stage C (ie, China Liver Cancer Staging (CNLC) stage III);

• with expect survival = 3 months;

• with obtained informed consent;

• will receive penpulimab and anlotinib combined with or without TACE.

Exclusion criteria:

• Contraindications of penpulimab and anlotinib;

• Child-Pugh C;

• Key information (such as imaging, liver function, Eastern Cooperative Oncology Group(ECOG) score, etc.) missing.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Zhongda Hospital Affiliated to Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

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