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

RecruitingPhase 3Ages 18 Years - 75 YearsAllChia Tai Tianqing Pharmaceutical Group Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) โ‰ค 1; Predicted survival โ‰ฅ12 weeks. * Subjects with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or who meet the diagnostic criteria for Primary Liver Cancer 2022 or the American Association for the Study of Hepatology (AASLD) hepatocellular carcinoma. * Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to randomization (multiple modalities or combined or multiple treatments are not acceptable). * No major vena portae 3 (Vp3) or vena portae 4 (Vp4) in the portal vein or any level of vascular invasion in the hepatic vein or inferior vena cava. * No extrahepatic metastasis. * High risk factors for recurrence after radical resection or complete ablation. * Complete recovery from surgical resection or ablation within 4 weeks before randomization. Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology. * Evidence of residual, recurrent, or metastatic disease at randomization. * More than one surgical treatment for hepatocellular carcinoma; Received more than 1 prophylactic Transcatheter Arterial Chemoembolization (TACE) treatment after surgery; or received Hepatic Artery Infusion Chemotherapy (HAIC) therapy after surgery. * Previous use of antiangiogenic drugs or PD-1, Programmed Cell Death-Ligand 1 (PD-L1) and other related immunotherapy drugs or systemic chemotherapy drugs.
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What it tests

  • Anlotinib hydrochloride capsules, Penpulimab injection
  • Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
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Where

67 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Peking Union Medical College Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing Friendship hospital of Capital Medical University
Beijing, China
Beijing YouAn Hospital,Capital Medical University
Beijing, China

โ€ฆand 59 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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