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

Last updated: May 15, 2023
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Cancer/tumors

Digestive System Neoplasms

Treatment

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

Anlotinib hydrochloride capsules, Penpulimab injection

Clinical Study ID

NCT05862337
ALTN-AK105-III-06
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 cytologyor who meet the diagnostic criteria for Primary Liver Cancer 2022 or the AmericanAssociation for the Study of Hepatology (AASLD) hepatocellular carcinoma.
  • Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) orMicrowave Ablation (MWA) only) within 4 to 12 weeks prior to randomization (multiplemodalities 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 ofvascular 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 beforerandomization.

Exclusion

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCChistology.
  • Evidence of residual, recurrent, or metastatic disease at randomization.
  • More than one surgical treatment for hepatocellular carcinoma; Received more than 1prophylactic 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.

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
Phase: 3
Study Start date:
May 10, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233000
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230000
    China

    Site Not Available

  • Beijing Friendship hospital of Capital Medical University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Beijing YouAn Hospital,Capital Medical University

    Beijing, Beijing 100069
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100005
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing 404199
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350011
    China

    Active - Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu 730000
    China

    Active - Recruiting

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730700
    China

    Active - Recruiting

  • Lanzhou University First Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Guangdong People's Hospital

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi 530000
    China

    Site Not Available

  • Guizhou Provincial People'S Hospital

    Guiyang, Guizhou 550002
    China

    Active - Recruiting

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou 550008
    China

    Site Not Available

  • Affiliated Hospital Of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Active - Recruiting

  • Hainan Provincial People's Hospital

    Haikou, Hainan 570311
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan 570311
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

  • Hunan Provincial People's Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

  • The Third Xiang Ya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia 240000
    China

    Active - Recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Active - Recruiting

  • Jiangsu Province People's Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226006
    China

    Active - Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu 226361
    China

    Site Not Available

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi 341099
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330000
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin 130012
    China

    Site Not Available

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116027
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning 121012
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110801
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • The Sixth People's Hospital of Shen Yang

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Binzhou Medical University Hospital

    BinZhou, Shandong 256699
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • The First Affiliated Hospital of Naval Medical University

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Third Affiliated Hospital of Naval Medical University

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Baoji Central Hospital

    Baoji, Shanxi 721000
    China

    Active - Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi 46000
    China

    Active - Recruiting

  • First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an, Shanxi 710038
    China

    Site Not Available

  • Xi'an International Medical Center Hospital

    Xi'an, Shanxi 710117
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Active - Recruiting

  • Affiliated Hospital Of North Sichuan Medical College

    Nanchong, Sichuan 637000
    China

    Active - Recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin 300308
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300181
    China

    Active - Recruiting

  • Tianjin Third Central Hospital

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhetiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang 315000
    China

    Active - Recruiting

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang 312000
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang 317000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

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