Trial Title:
Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
NCT ID:
NCT05862337
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib hydrochloride capsules, Penpulimab injection
Description:
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).
Arm group label:
Anlotinib hydrochloride capsules + Penpulimab injection
Intervention type:
Drug
Intervention name:
Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
Description:
placebo control, no active substance.
Arm group label:
Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Zheng, Doctor
Phone:
+86 13721179461
Email:
luzhengdr@163.com
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lianxin Liu, Doctor
Phone:
+86 18096656677
Email:
liulx@ustc.edu.cn
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yufeng Gao, Doctor
Phone:
+86 13956938032
Email:
aygyf@126.com
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Zhao, Doctor
Phone:
+86 13901246374
Email:
zhaoht@pumch.cn
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100020
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongguang Wang, Doctor
Phone:
+86 13717659265
Email:
wanghongguang301@163.com
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Chen, Doctor
Phone:
+86 13911995059
Email:
chenlei@pkuph.edu.cn
Facility:
Name:
Beijing Friendship hospital of Capital Medical University
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongtao Zhang, Doctor
Phone:
+86 13801060364
Email:
zhangzht@ccmu.edu.cn
Facility:
Name:
Beijing YouAn Hospital,Capital Medical University
Address:
City:
Beijing
Zip:
100069
Country:
China
Status:
Recruiting
Contact:
Last name:
Yonghong Zhang, Doctor
Phone:
+86 13810108505
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dewei Li, Doctor
Phone:
+86 13618317772
Email:
lidewei406@sina.com
Facility:
Name:
Chongqing University Three Gorges Hospital
Address:
City:
Chongqing
Zip:
404199
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xuan An, Master
Phone:
+86 13996835633
Email:
57485971@qq.com
Facility:
Name:
Mengchao Hepatobiliary Hospital of Fujian Medical
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Li, Doctor
Phone:
+86 18950242262
Email:
lht45182@163.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350011
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingfeng Liu, Doctor
Phone:
+86 13905029580
Email:
drjingfeng@126.com
Facility:
Name:
Gansu Provincial Cancer Hospital
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Yang, Bachelor
Phone:
+86 13639395521
Email:
Yangyantd1992@163.com
Facility:
Name:
Lanzhou University First Hospital
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lei Zhang, Doctor
Phone:
+86 13993181644
Email:
13993181644@139.com
Facility:
Name:
Lanzhou University Second Hospital
Address:
City:
Lanzhou
Zip:
730030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wence Zhou, Doctor
Phone:
+86 13893699909
Email:
Zhouwc129@163.com
Facility:
Name:
Gansu Provincial Hospital
Address:
City:
Lanzhou
Zip:
730700
Country:
China
Status:
Recruiting
Contact:
Last name:
Minggang Zheng, Doctor
Phone:
+86 13893260496
Email:
zhengninggang0707@163.com
Facility:
Name:
Guangdong People's Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haosheng Jin, Doctor
Phone:
+86 13825066891
Email:
kinghaos@126.com
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Gao, Doctor
Phone:
+86 18922345399
Email:
gaoyi6146@163.com
Facility:
Name:
The Third Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510630
Country:
China
Status:
Recruiting
Contact:
Last name:
Chan Xie, Doctor
Phone:
+86 13434383329
Email:
happyxiechan@hotmail.com
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Feixiang Wu, Doctor
Phone:
+86 13707873326
Email:
wufx2013@163.com
Facility:
Name:
Guizhou Provincial People'S Hospital
Address:
City:
Guiyang
Zip:
550002
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Liu, Doctor
Phone:
+86 13985519359
Email:
LiuJun2018@126.com
Facility:
Name:
The Affiliated Cancer Hospital of Guizhou Medical University
Address:
City:
Guiyang
Zip:
550008
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xing Wang, Doctor
Phone:
+86 13608512435
Email:
59434479@qq.com
Facility:
Name:
Affiliated Hospital Of Zunyi Medical University
Address:
City:
Zunyi
Zip:
563000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lijin Zhao, Doctor
Phone:
+86 13668526996
Email:
386421696@qq.com
Facility:
Name:
Hainan Provincial People's Hospital
Address:
City:
Haikou
Zip:
570311
Country:
China
Status:
Recruiting
Contact:
Last name:
Jincai Wu, Doctor
Phone:
+86 18889765723
Email:
wujincai021@126.com
Facility:
Name:
The Second Affiliated Hospital of Hainan Medical University
Address:
City:
Haikou
Zip:
570311
Country:
China
Status:
Recruiting
Contact:
Last name:
Haifeng Lin, Bachelor
Phone:
+86 13322060949
Email:
13322060949@163.com
Facility:
Name:
Affiliated Cancer Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Yubao Zhang, Doctor
Phone:
+86 13936588077
Email:
zhyb88077@sina.com
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471000
Country:
China
Status:
Recruiting
Contact:
Last name:
Dianbao Zhang, Doctor
Phone:
+86 15038628192
Email:
doctorzhangdianbao@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuling Sun, Doctor
Phone:
+86 13837184328
Email:
doctorssh@126.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongtao Hu, Doctor
Phone:
+86 13592616373
Email:
13592616373@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jia Luo, Doctor
Phone:
+86 13874994359
Email:
luojia@hnca.org.cn
Facility:
Name:
Hunan Provincial People's Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chuang Peng, Doctor
Phone:
+86 15974220718
Email:
1518364280@qq.com
Facility:
Name:
The Third Xiang Ya Hospital of Central South University
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Feizhou Huang, Doctor
Phone:
+86 18975186183
Email:
Huangfeizhou1009@163.com
Facility:
Name:
Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ledu Zhou, Doctor
Phone:
+86 17373120367
Email:
csuzld@126.com
Facility:
Name:
Chifeng Municipal Hospital
Address:
City:
Chifeng
Zip:
240000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhonghua Liu, Bachelor
Phone:
+86 18047660067
Email:
M18047660067@163.com
Facility:
Name:
The First People's Hospital of Changzhou
Address:
City:
Changzhou
Zip:
213000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuemin Chen, Doctor
Phone:
+86 13813587333
Email:
czcxm007@126.com
Facility:
Name:
Jiangsu Province People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangcheng Li, Doctor
Phone:
+86 18951999088
Email:
drlixc@163.com
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226006
Country:
China
Status:
Recruiting
Contact:
Last name:
Shudong Gu, Doctor
Phone:
+86 15851392808
Email:
gusdnt@foxmail.com
Facility:
Name:
Nantong Tumor Hospital
Address:
City:
Nantong
Zip:
226361
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Bingfeng Shao, Bachelor
Phone:
+86 13962981592
Email:
ntzlsbf@163.com
Facility:
Name:
Ganzhou People's Hospital
Address:
City:
Ganzhou
Zip:
341099
Country:
China
Status:
Recruiting
Contact:
Last name:
Song Zou, Bachelor
Phone:
+86 13879757375
Email:
1758771@qq.com
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Recruiting
Contact:
Last name:
Linquan Wu, Doctor
Phone:
+86 13607912265
Email:
wulqnc@163.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Cheng, Doctor
Phone:
+86 13943012851
Email:
jl.cheng@163.com
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116027
Country:
China
Status:
Recruiting
Contact:
Last name:
Liming Wang, Doctor
Phone:
+86 17709870007
Email:
wangbcc259@163.com
Facility:
Name:
The First Affiliated Hospital of Jinzhou Medical University
Address:
City:
Jinzhou
Zip:
121012
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongzhi Sun, Doctor
Phone:
+86 13840650008
Email:
cmushz@163.com
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chaoliu Dai, Doctor
Phone:
+86 18940251697
Email:
daicl@sj-hospital.org
Facility:
Name:
The Sixth People's Hospital of Shen Yang
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Wu, Bachelor
Phone:
+86 18502460420
Email:
wuwei19700420@sina.com
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiangdong Hua, Doctor
Phone:
+86 13940126803
Email:
LnzlHxd@163.com
Facility:
Name:
Binzhou Medical University Hospital
Address:
City:
BinZhou
Zip:
256699
Country:
China
Status:
Recruiting
Contact:
Last name:
Fangling Ning, Master
Phone:
+86 15254311599
Email:
ningfangling@126.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lei Zhao, Doctor
Phone:
+86 18615216153
Email:
drzhaolei1974@163.com
Facility:
Name:
The First Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Jijin Yang, Doctor
Phone:
+86 13801676237
Email:
jijinyang@sina.com
Facility:
Name:
Third Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Shen, Doctor
Phone:
+86 13901651428
Email:
shenfengehbh@sina.com
Facility:
Name:
Baoji Central Hospital
Address:
City:
Baoji
Zip:
721000
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Wang, Bachelor
Phone:
+86 13892780368
Email:
wangg1971@163.com
Facility:
Name:
Heping Hospital Affiliated to Changzhi Medical College
Address:
City:
Changzhi
Zip:
46000
Country:
China
Status:
Recruiting
Contact:
Last name:
Buqiang Wu, Doctor
Phone:
+86 13934055258
Email:
wuli67@163.com
Facility:
Name:
The Second Affiliated Hospital of Air Force Medical University
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xilin Du, Doctor
Phone:
+86 13709267808
Email:
dxlin0705@163.com
Facility:
Name:
First Affiliated Hospital of Xian Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huanchen Sha, Doctor
Phone:
+86 13152167215
Email:
shahuanchen229@xjtufh.edu.cn
Facility:
Name:
Xi'an International Medical Center Hospital
Address:
City:
Xi'an
Zip:
710117
Country:
China
Status:
Recruiting
Contact:
Last name:
Guohong Han
Phone:
+86 13991969930
Email:
13991969930@126.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Wu, Doctor
Phone:
+86 18980601958
Email:
wuhong7801@163.com
Facility:
Name:
Affiliated Hospital of Southwest Medical University
Address:
City:
Luzhou
Zip:
646000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qinglian Wen, Doctor
Phone:
+86 13518388130
Email:
zlkgcpqlw666@163.com
Facility:
Name:
Affiliated Hospital Of North Sichuan Medical College
Address:
City:
Nanchong
Zip:
637000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojie Ma, Master
Phone:
+86 13458406996
Email:
992437730@qq.com
Facility:
Name:
Tianjin Third Central Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fengmei Wang, Doctor
Phone:
+86 15522242696
Email:
wangfengmeitj@126.com
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Recruiting
Contact:
Last name:
Ningning Zhang, Doctor
Phone:
+86 15822153931
Email:
mail4ningning@163.com
Facility:
Name:
Tianjin Cancer Hospital Airport Hospital
Address:
City:
Tianjin
Zip:
300308
Country:
China
Status:
Recruiting
Contact:
Last name:
Huikai Li, Doctor
Phone:
+86 18622228639
Email:
lihuikai@tjmuch.com
Facility:
Name:
The First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weixin Reng, Doctor
Phone:
+86 13909911031
Email:
rwx1031@163.com
Facility:
Name:
Sir Run Run Shaw Hospital Zhetiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiujun Cai, Doctor
Phone:
+86 13805738266
Email:
srrsh_cxj@zju.edu.cn
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Zip:
315000
Country:
China
Status:
Recruiting
Contact:
Last name:
Shengdong Wu, Doctor
Phone:
+86 13567886669
Email:
arsdrell@hotmail.com
Facility:
Name:
Shaoxing People's Hospital
Address:
City:
Shaoxing
Zip:
312000
Country:
China
Status:
Recruiting
Contact:
Last name:
Baochun Lu, Doctor
Phone:
+86 13002638081
Email:
lbc111@yeah.net
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Zip:
317000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fabiao Zhang, Master
Phone:
+86 13706760105
Email:
Zhangfabiao@enzemed.com
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chang Yu, Doctor
Phone:
+86 13906650823
Email:
wzmcyc@126.com
Start date:
May 10, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862337
