A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study of Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection in Patients With High Risk of Relapse After Radical Surgery or Ablation of Hepatocellular Carcinoma (HCC).
Status: Recruiting
Location: See all (67) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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 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.
Locations
Other Locations
China
Baoji Central Hospital
RECRUITING
Baoji
Beijing Friendship hospital of Capital Medical University
RECRUITING
Beijing
Beijing YouAn Hospital,Capital Medical University
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Binzhou Medical University Hospital
RECRUITING
Binzhou
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Hunan Provincial People's Hospital
NOT_YET_RECRUITING
Changsha
The Third Xiang Ya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Heping Hospital Affiliated to Changzhi Medical College
RECRUITING
Changzhi
The First People's Hospital of Changzhou
RECRUITING
Changzhou
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chifeng Municipal Hospital
RECRUITING
Chifeng
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Chongqing University Three Gorges Hospital
NOT_YET_RECRUITING
Chongqing
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Fujian Cancer Hospital
RECRUITING
Fuzhou
Mengchao Hepatobiliary Hospital of Fujian Medical
RECRUITING
Fuzhou
Ganzhou People's Hospital
RECRUITING
Ganzhou
Guangdong People's Hospital
NOT_YET_RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Guizhou Provincial People'S Hospital
RECRUITING
Guiyang
The Affiliated Cancer Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Hainan Provincial People's Hospital
RECRUITING
Haikou
The Second Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
Sir Run Run Shaw Hospital Zhetiang University School of Medicine
RECRUITING
Hangzhou
Affiliated Cancer Hospital of Harbin Medical University
RECRUITING
Harbin
Anhui Provincial Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Jinzhou Medical University
RECRUITING
Jinzhou
Gansu Provincial Cancer Hospital
RECRUITING
Lanzhou
Gansu Provincial Hospital
RECRUITING
Lanzhou
Lanzhou University First Hospital
NOT_YET_RECRUITING
Lanzhou
Lanzhou University Second Hospital
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Affiliated Hospital Of North Sichuan Medical College
RECRUITING
Nanchong
Jiangsu Province People's Hospital
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Nantong Tumor Hospital
NOT_YET_RECRUITING
Nantong
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Naval Medical University
RECRUITING
Shanghai
Third Affiliated Hospital of Naval Medical University
RECRUITING
Shanghai
Shaoxing People's Hospital
RECRUITING
Shaoxing
Liaoning Cancer Hospital
NOT_YET_RECRUITING
Shenyang
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Sixth People's Hospital of Shen Yang
RECRUITING
Shenyang
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Tianjin Cancer Hospital Airport Hospital
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Tianjin Third Central Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
First Affiliated Hospital of Xian Jiaotong University
NOT_YET_RECRUITING
Xi’an
The Second Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITING
Xi’an
Xi'an International Medical Center Hospital
RECRUITING
Xi’an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Affiliated Hospital Of Zunyi Medical University
RECRUITING
Zunyi
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 480
Treatments
Experimental: Anlotinib hydrochloride capsules + Penpulimab injection
Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle.
Placebo_comparator: Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo
Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.