Clinical trial NCT05344924: TACE Combined With Penpulimab and Anlotinib for Advanced HCC
Official title: Transarterial Chemoembolization Combined With Penpulimab and Anlotinib for Advanced Hepatocellular Carcinoma：A Nationwide Multicenter Prospective Real-world Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Transarterial chemoembolization
Penpulimab
Anlotinib
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: up to 5 years
measure: Adverse effects
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Affiliated to Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References: