Phase
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
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui 233000
ChinaActive - Recruiting
Anhui Provincial Hospital
Hefei, Anhui 230000
ChinaActive - Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230000
ChinaSite Not Available
Beijing Friendship hospital of Capital Medical University
Beijing, Beijing 100050
ChinaActive - Recruiting
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing 100069
ChinaActive - Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing 100020
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing, Beijing 100005
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing 400030
ChinaSite Not Available
Chongqing University Three Gorges Hospital
Chongqing, Chongqing 404199
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou, Fujian 350011
ChinaActive - Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical
Fuzhou, Fujian 350001
ChinaActive - Recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu 730000
ChinaActive - Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu 730700
ChinaActive - Recruiting
Lanzhou University First Hospital
Lanzhou, Gansu 730000
ChinaSite Not Available
Lanzhou University Second Hospital
Lanzhou, Gansu 730030
ChinaSite Not Available
Guangdong People's Hospital
Guangzhou, Guangdong 510000
ChinaSite Not Available
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510630
ChinaActive - Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong 510280
ChinaActive - Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi 530000
ChinaSite Not Available
Guizhou Provincial People'S Hospital
Guiyang, Guizhou 550002
ChinaActive - Recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou 550008
ChinaSite Not Available
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou 563000
ChinaActive - Recruiting
Hainan Provincial People's Hospital
Haikou, Hainan 570311
ChinaActive - Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan 570311
ChinaActive - Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang 150081
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471000
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan 410000
ChinaSite Not Available
Hunan Provincial People's Hospital
Changsha, Hunan 410000
ChinaSite Not Available
The Third Xiang Ya Hospital of Central South University
Changsha, Hunan 410000
ChinaActive - Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan 410000
ChinaSite Not Available
Chifeng Municipal Hospital
Chifeng, Inner Mongolia 240000
ChinaActive - Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu 213000
ChinaActive - Recruiting
Jiangsu Province People's Hospital
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu 226006
ChinaActive - Recruiting
Nantong Tumor Hospital
Nantong, Jiangsu 226361
ChinaSite Not Available
Ganzhou People's Hospital
Ganzhou, Jiangxi 341099
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330000
ChinaActive - Recruiting
Jilin Cancer Hospital
Changchun, Jilin 130012
ChinaSite Not Available
The Second Hospital of Dalian Medical University
Dalian, Liaoning 116027
ChinaActive - Recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning 121012
ChinaActive - Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning 110801
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110000
ChinaSite Not Available
The Sixth People's Hospital of Shen Yang
Shenyang, Liaoning 110000
ChinaActive - Recruiting
Binzhou Medical University Hospital
BinZhou, Shandong 256699
ChinaActive - Recruiting
Shandong Cancer Hospital
Jinan, Shandong 250117
ChinaSite Not Available
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Baoji Central Hospital
Baoji, Shanxi 721000
ChinaActive - Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi 46000
ChinaActive - Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shanxi 710061
ChinaSite Not Available
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shanxi 710038
ChinaSite Not Available
Xi'an International Medical Center Hospital
Xi'an, Shanxi 710117
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan 610000
ChinaActive - Recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan 646000
ChinaActive - Recruiting
Affiliated Hospital Of North Sichuan Medical College
Nanchong, Sichuan 637000
ChinaActive - Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin 300308
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin 300181
ChinaActive - Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin 300000
ChinaActive - Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang 830000
ChinaSite Not Available
Sir Run Run Shaw Hospital Zhetiang University School of Medicine
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang 315000
ChinaActive - Recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang 312000
ChinaActive - Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang 317000
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaActive - Recruiting

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