TACE Combined With Penpulimab and Anlotinib for Advanced HCC

Southeast University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05344924

CHANCE 2205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Cohort I（TACE-A-A Cohort）

Experimental group

Description:

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.

Treatment:

Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib

Cohort II (A-A Cohort)

Experimental group

Description:

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.

Treatment:

Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib