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OncoMatch/Clinical Trials/NCT05862337

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

Is NCT05862337 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Anlotinib hydrochloride capsules, Penpulimab for hepatocellular carcinoma.

Phase 3RecruitingChia Tai Tianqing Pharmaceutical Group Co., Ltd.NCT05862337Data as of May 2026

Treatment: Anlotinib hydrochloride capsules, PenpulimabThe 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).

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: surgical resection or ablation — curative

Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to randomization

Cannot have received: systemic chemotherapy

Previous use of ... systemic chemotherapy drugs

Cannot have received: antiangiogenic drugs

Previous use of antiangiogenic drugs

Cannot have received: PD-1 inhibitor

Previous use of ... PD-1 ... immunotherapy drugs

Cannot have received: anti-PD-L1 therapy

Previous use of ... Programmed Cell Death-Ligand 1 (PD-L1) ... immunotherapy drugs

Cannot have received: prophylactic TACE

Exception: more than 1 prophylactic TACE after surgery

Received more than 1 prophylactic Transcatheter Arterial Chemoembolization (TACE) treatment after surgery

Cannot have received: HAIC

received Hepatic Artery Infusion Chemotherapy (HAIC) therapy after surgery

Cannot have received: multiple surgical treatments

Exception: more than one surgical treatment for hepatocellular carcinoma

More than one surgical treatment for hepatocellular carcinoma

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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