Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization, Penpulimab, Anlotinib
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.
Interventions
DRUGTACE+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.
Sponsors
Zhongda Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactHai-Dong Zhu, MD
Backup ContactRi Li, MS
Outcome results
None listed