Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT05862337
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) β€ 1; Predicted survival β₯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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anlotinib hydrochloride capsules + Penpulimab injection Anlotinib hydrochloride capsules, Penpulimab injection Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle. Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
- Primary Outcome Measures
Name Time Method Recurrence-free survival (RFS) Baseline up to 3 years. RFS assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, or death from any cause, whichever occurred first.
- Secondary Outcome Measures
Name Time Method Time to recurrence(TTR) Baseline up to 3 years. TTR assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, whichever occurred first.
Time to extrahepatic metastasis or macrovascular invasion Baseline up to 3 years. Time to extrahepatic metastasis or macrovascular invasion as assessed by the investigator.
Overall survival (OS) Baseline up to 3 years. OS defined as the time from the date of randomization until the date of death due to any cause.
Objective response rate (ORR) after first recurrence Baseline up to 3 years. subjects with evaluable tumor lesion status who were cross-treated with Anlotinib hydrochloride capsules combined with Penpulimab injection developed complete response or partial response after a first HCC relapse as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Trial Locations
- Locations (67)
The Third Affiliated Hospital of Sun Yat-sen University
π¨π³Guangzhou, Guangdong, China
Ganzhou People's Hospital
π¨π³Ganzhou, Jiangxi, China
Heping Hospital Affiliated to Changzhi Medical College
π¨π³Changzhi, Shanxi, China
Affiliated Hospital of Southwest Medical University
π¨π³Luzhou, Sichuan, China
Cancer Hospital Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Peking Union Medical College Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Bengbu Medical College
π¨π³Bengbu, Anhui, China
Anhui Provincial Hospital
π¨π³Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, Anhui, China
Peking University People's Hospital
π¨π³Beijing, Beijing, China
Chongqing University Cancer Hospital
π¨π³Chongqing, Chongqing, China
Beijing Friendship hospital of Capital Medical University
π¨π³Beijing, Beijing, China
Beijing YouAn Hospital,Capital Medical University
π¨π³Beijing, Beijing, China
Mengchao Hepatobiliary Hospital of Fujian Medical
π¨π³Fuzhou, Fujian, China
Chongqing University Three Gorges Hospital
π¨π³Chongqing, Chongqing, China
Gansu Provincial Cancer Hospital
π¨π³Lanzhou, Gansu, China
Lanzhou University Second Hospital
π¨π³Lanzhou, Gansu, China
Lanzhou University First Hospital
π¨π³Lanzhou, Gansu, China
Gansu Provincial Hospital
π¨π³Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
π¨π³Guangzhou, Guangdong, China
Guangdong People's Hospital
π¨π³Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
π¨π³Nanning, Guangxi, China
Guizhou Provincial People'S Hospital
π¨π³Guiyang, Guizhou, China
The Affiliated Cancer Hospital of Guizhou Medical University
π¨π³Guiyang, Guizhou, China
Hainan Provincial People's Hospital
π¨π³Haikou, Hainan, China
Affiliated Hospital Of Zunyi Medical University
π¨π³Zunyi, Guizhou, China
Affiliated Cancer Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
The Second Affiliated Hospital of Hainan Medical University
π¨π³Haikou, Hainan, China
The First Affiliated Hospital of Henan University of Science and Technology
π¨π³Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
The Third Xiang Ya Hospital of Central South University
π¨π³Changsha, Hunan, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
Hunan Provincial People's Hospital
π¨π³Changsha, Hunan, China
Chifeng Municipal Hospital
π¨π³Chifeng, Inner Mongolia, China
Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
The First People's Hospital of Changzhou
π¨π³Changzhou, Jiangsu, China
Jiangsu Province People's Hospital
π¨π³Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
π¨π³Nantong, Jiangsu, China
Nantong Tumor Hospital
π¨π³Nantong, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
Jilin Cancer Hospital
π¨π³Changchun, Jilin, China
The Second Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
π¨π³Jinzhou, Liaoning, China
The Sixth People's Hospital of Shen Yang
π¨π³Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Shandong Cancer Hospital
π¨π³Jinan, Shandong, China
Third Affiliated Hospital of Naval Medical University
π¨π³Shanghai, Shanghai, China
Binzhou Medical University Hospital
π¨π³BinZhou, Shandong, China
The First Affiliated Hospital of Naval Medical University
π¨π³Shanghai, Shanghai, China
Liaoning Cancer Hospital
π¨π³Shenyang, Liaoning, China
Baoji Central Hospital
π¨π³Baoji, Shanxi, China
First Affiliated Hospital of Xian Jiaotong University
π¨π³Xi'an, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University
π¨π³Xi'an, Shanxi, China
Xi'an International Medical Center Hospital
π¨π³Xi'an, Shanxi, China
West China Hospital of Sichuan University
π¨π³Chengdu, Sichuan, China
Affiliated Hospital Of North Sichuan Medical College
π¨π³Nanchong, Sichuan, China
Sir Run Run Shaw Hospital Zhetiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Tianjin Third Central Hospital
π¨π³Tianjin, Tianjin, China
Tianjin Cancer Hospital Airport Hospital
π¨π³Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
π¨π³Tianjin, Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
π¨π³ΓrΓΌmqi, Xinjiang, China
Shaoxing People's Hospital
π¨π³Shaoxing, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
π¨π³Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang Province
π¨π³Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
π¨π³Wenzhou, Zhejiang, China
Fujian Cancer Hospital
π¨π³Fuzhou, Fujian, China