TACE Combined With Penpulimab and Anlotinib for Advanced HCC

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

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.

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.

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.