Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
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).
1 other identifier
interventional
480
1 country
67
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hepatocellular-carcinoma
Started May 2023
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2023
CompletedFirst Submitted
Initial submission to the registry
May 15, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMay 17, 2023
July 1, 2022
1.2 years
May 15, 2023
May 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence-free survival (RFS)
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.
Baseline up to 3 years.
Secondary Outcomes (4)
Time to recurrence(TTR)
Baseline up to 3 years.
Time to extrahepatic metastasis or macrovascular invasion
Baseline up to 3 years.
Overall survival (OS)
Baseline up to 3 years.
Objective response rate (ORR) after first recurrence
Baseline up to 3 years.
Study Arms (2)
Anlotinib hydrochloride capsules + Penpulimab injection
EXPERIMENTALAnlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle.
Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo
PLACEBO COMPARATORAnlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
Interventions
Anlotinib hydrochloride capsules is a multitargeted receptor tyrosine kinase inhibitor. Penpulimab injection is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1).
placebo control, no active substance.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100020, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship hospital of Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404199, China
Mengchao Hepatobiliary Hospital of Fujian Medical
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350011, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000, China
Lanzhou University First Hospital
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730700, China
Guangdong People's Hospital
Guangzhou, Guangdong, 510000, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530000, China
Guizhou Provincial People'S Hospital
Guiyang, Guizhou, 550002, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550008, China
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Hainan Provincial People's Hospital
Haikou, Hainan, 570311, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410000, China
The Third Xiang Ya Hospital of Central South University
Changsha, Hunan, 410000, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 240000, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210000, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226361, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341099, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
The Sixth People's Hospital of Shen Yang
Shenyang, Liaoning, 110000, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256699, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433, China
Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433, China
Baoji Central Hospital
Baoji, Shanxi, 721000, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 46000, China
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710038, China
First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061, China
Xi'an International Medical Center Hospital
Xi’an, Shanxi, 710117, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Affiliated Hospital Of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300181, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Sir Run Run Shaw Hospital Zhetiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2023
First Posted
May 17, 2023
Study Start
May 10, 2023
Primary Completion
August 1, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
May 17, 2023
Record last verified: 2022-07