Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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 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.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Anhui Provincial HospitalRecruiting
- The First Affiliated Hospital of Anhui Medical University
- Peking Union Medical College HospitalRecruiting
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
- Peking University People's HospitalRecruiting
- Beijing Friendship hospital of Capital Medical UniversityRecruiting
- Beijing YouAn Hospital,Capital Medical UniversityRecruiting
- Chongqing University Cancer Hospital
- Chongqing University Three Gorges Hospital
- Mengchao Hepatobiliary Hospital of Fujian MedicalRecruiting
- Fujian Cancer HospitalRecruiting
- Gansu Provincial Cancer HospitalRecruiting
- Lanzhou University First Hospital
- Lanzhou University Second Hospital
- Gansu Provincial HospitalRecruiting
- Guangdong People's Hospital
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- Guangxi Medical University Affiliated Tumor Hospital
- Guizhou Provincial People'S HospitalRecruiting
- The Affiliated Cancer Hospital of Guizhou Medical University
- Affiliated Hospital Of Zunyi Medical UniversityRecruiting
- Hainan Provincial People's HospitalRecruiting
- The Second Affiliated Hospital of Hainan Medical UniversityRecruiting
- Affiliated Cancer Hospital of Harbin Medical UniversityRecruiting
- The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Henan Cancer Hospital
- Hunan Cancer Hospital
- Hunan Provincial People's Hospital
- The Third Xiang Ya Hospital of Central South UniversityRecruiting
- Xiangya Hospital of Central South University
- Chifeng Municipal HospitalRecruiting
- The First People's Hospital of ChangzhouRecruiting
- Jiangsu Province People's HospitalRecruiting
- Affiliated Hospital of Nantong UniversityRecruiting
- Nantong Tumor Hospital
- Ganzhou People's HospitalRecruiting
- The Second Affiliated Hospital of Nanchang UniversityRecruiting
- Jilin Cancer Hospital
- The Second Hospital of Dalian Medical UniversityRecruiting
- The First Affiliated Hospital of Jinzhou Medical UniversityRecruiting
- Shengjing Hospital of China Medical University
- The Sixth People's Hospital of Shen YangRecruiting
- Liaoning Cancer Hospital
- Binzhou Medical University HospitalRecruiting
- Shandong Cancer Hospital
- The First Affiliated Hospital of Naval Medical UniversityRecruiting
- Third Affiliated Hospital of Naval Medical UniversityRecruiting
- Baoji Central HospitalRecruiting
- Heping Hospital Affiliated to Changzhi Medical CollegeRecruiting
- The Second Affiliated Hospital of Air Force Medical University
- First Affiliated Hospital of Xian Jiaotong University
- Xi'an International Medical Center HospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- Affiliated Hospital of Southwest Medical UniversityRecruiting
- Affiliated Hospital Of North Sichuan Medical CollegeRecruiting
- Tianjin Third Central HospitalRecruiting
- Tianjin Medical University Cancer Institute & HospitalRecruiting
- Tianjin Cancer Hospital Airport HospitalRecruiting
- The First Affiliated Hospital of Xinjiang Medical University
- Sir Run Run Shaw Hospital Zhetiang University School of MedicineRecruiting
- Ningbo Medical Center Lihuili HospitalRecruiting
- Shaoxing People's HospitalRecruiting
- Taizhou Hospital of Zhejiang ProvinceRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Anlotinib hydrochloride capsules + Penpulimab injection
Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo
Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle.
Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.