Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.

Recruiting Phase 3 Interventional Study
Hepatocellular Carcinoma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
480 (estimated)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
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About This Trial

The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1; Predicted survival ≥12 weeks. * Subjects with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or who meet the diagnostic criteria for Primary Liver Cancer 2022 or …
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