Hepatocellular CarcinomaPhase 3NCT05862337
Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
A Phase 3 study testing Anlotinib hydrochloride capsules, Penpulimab injection in people with Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 67 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Anlotinib hydrochloride capsules, Penpulimab injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 67 sitesChina
- Study dates
- 10 May 2023to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
67 sites in 1 country. Contact the study team or a site near you to ask about taking part.
67 sites in 1 country
China67 sites, 67 recruiting
- Recruiting
Baoji Central Hospital
Baoji, Shanxi, 721000
Gang Wang, Bachelor, +86 13892780368, wangg1971@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Haitao Zhao, Doctor, +86 13901246374, zhaoht@pumch.cn
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100020
Hongguang Wang, Doctor, +86 13717659265, wanghongguang301@163.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Lei Chen, Doctor, +86 13911995059, chenlei@pkuph.edu.cn
- Recruiting
Beijing Friendship hospital of Capital Medical University
Beijing, Beijing Municipality, 100050
Zhongtao Zhang, Doctor, +86 13801060364, zhangzht@ccmu.edu.cn
- Recruiting
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069
Yonghong Zhang, Doctor, +86 13810108505
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Lu Zheng, Doctor, +86 13721179461, luzhengdr@163.com
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, 256699
Fangling Ning, Master, +86 15254311599, ningfangling@126.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Ying Cheng, Doctor, +86 13943012851, jl.cheng@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Jia Luo, Doctor, +86 13874994359, luojia@hnca.org.cn
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410000
Chuang Peng, Doctor, +86 15974220718, 1518364280@qq.com
- Recruiting
The Third Xiang Ya Hospital of Central South University
Changsha, Hunan, 410000
Feizhou Huang, Doctor, +86 18975186183, Huangfeizhou1009@163.com
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Ledu Zhou, Doctor, +86 17373120367, csuzld@126.com
- Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 46000
Buqiang Wu, Doctor, +86 13934055258, wuli67@163.com
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000
Xuemin Chen, Doctor, +86 13813587333, czcxm007@126.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Hong Wu, Doctor, +86 18980601958, wuhong7801@163.com
- Recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 240000
Zhonghua Liu, Bachelor, +86 18047660067, M18047660067@163.com
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Dewei Li, Doctor, +86 13618317772, lidewei406@sina.com
- Not yet recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404199
Xuan An, Master, +86 13996835633, 57485971@qq.com
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Liming Wang, Doctor, +86 17709870007, wangbcc259@163.com
- Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical
Fuzhou, Fujian, 350001
Haitao Li, Doctor, +86 18950242262, lht45182@163.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350011
Jingfeng Liu, Doctor, +86 13905029580, drjingfeng@126.com
- Recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341099
Song Zou, Bachelor, +86 13879757375, 1758771@qq.com
- Not yet recruiting
Guangdong People's Hospital
Guangzhou, Guangdong, 510000
Haosheng Jin, Doctor, +86 13825066891, kinghaos@126.com
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Yi Gao, Doctor, +86 18922345399, gaoyi6146@163.com
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Chan Xie, Doctor, +86 13434383329, happyxiechan@hotmail.com
- Recruiting
Guizhou Provincial People'S Hospital
Guiyang, Guizhou, 550002
Jun Liu, Doctor, +86 13985519359, LiuJun2018@126.com
- Not yet recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550008
Xing Wang, Doctor, +86 13608512435, 59434479@qq.com
- Recruiting
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
Jincai Wu, Doctor, +86 18889765723, wujincai021@126.com
- Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311
Haifeng Lin, Bachelor, +86 13322060949, 13322060949@163.com
- Recruiting
Sir Run Run Shaw Hospital Zhetiang University School of Medicine
Hangzhou, Zhejiang, 310000
Xiujun Cai, Doctor, +86 13805738266, srrsh_cxj@zju.edu.cn
- Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Yubao Zhang, Doctor, +86 13936588077, zhyb88077@sina.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Lianxin Liu, Doctor, +86 18096656677, liulx@ustc.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Yufeng Gao, Doctor, +86 13956938032, aygyf@126.com
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Lei Zhao, Doctor, +86 18615216153, drzhaolei1974@163.com
- Recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012
Hongzhi Sun, Doctor, +86 13840650008, cmushz@163.com
- Recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000
Yan Yang, Bachelor, +86 13639395521, Yangyantd1992@163.com
- Not yet recruiting
Lanzhou University First Hospital
Lanzhou, Gansu, 730000
Lei Zhang, Doctor, +86 13993181644, 13993181644@139.com
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Wence Zhou, Doctor, +86 13893699909, Zhouwc129@163.com
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730700
Minggang Zheng, Doctor, +86 13893260496, zhengninggang0707@163.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Dianbao Zhang, Doctor, +86 15038628192, doctorzhangdianbao@163.com
- Recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Qinglian Wen, Doctor, +86 13518388130, zlkgcpqlw666@163.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Linquan Wu, Doctor, +86 13607912265, wulqnc@163.com
- Recruiting
Affiliated Hospital Of North Sichuan Medical College
Nanchong, Sichuan, 637000
Xiaojie Ma, Master, +86 13458406996, 992437730@qq.com
- Recruiting
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210000
Xiangcheng Li, Doctor, +86 18951999088, drlixc@163.com
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530000
Feixiang Wu, Doctor, +86 13707873326, wufx2013@163.com
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006
Shudong Gu, Doctor, +86 15851392808, gusdnt@foxmail.com
- Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226361
Bingfeng Shao, Bachelor, +86 13962981592, ntzlsbf@163.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Shengdong Wu, Doctor, +86 13567886669, arsdrell@hotmail.com
- Recruiting
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
Jijin Yang, Doctor, +86 13801676237, jijinyang@sina.com
- Recruiting
Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
Feng Shen, Doctor, +86 13901651428, shenfengehbh@sina.com
- Recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
Baochun Lu, Doctor, +86 13002638081, lbc111@yeah.net
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
Chaoliu Dai, Doctor, +86 18940251697, daicl@sj-hospital.org
- Recruiting
The Sixth People's Hospital of Shen Yang
Shenyang, Liaoning, 110000
Wei Wu, Bachelor, +86 18502460420, wuwei19700420@sina.com
- Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
Xiangdong Hua, Doctor, +86 13940126803, LnzlHxd@163.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Fabiao Zhang, Master, +86 13706760105, Zhangfabiao@enzemed.com
- Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300000
Fengmei Wang, Doctor, +86 15522242696, wangfengmeitj@126.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300181
Ningning Zhang, Doctor, +86 15822153931, mail4ningning@163.com
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Huikai Li, Doctor, +86 18622228639, lihuikai@tjmuch.com
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Weixin Reng, Doctor, +86 13909911031, rwx1031@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Chang Yu, Doctor, +86 13906650823, wzmcyc@126.com
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710038
Xilin Du, Doctor, +86 13709267808, dxlin0705@163.com
- Not yet recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061
Huanchen Sha, Doctor, +86 13152167215, shahuanchen229@xjtufh.edu.cn
- Recruiting
Xi'an International Medical Center Hospital
Xi’an, Shanxi, 710117
Guohong Han, +86 13991969930, 13991969930@126.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yuling Sun, Doctor, +86 13837184328, doctorssh@126.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Hongtao Hu, Doctor, +86 13592616373, 13592616373@163.com
- Recruiting
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou, 563000
Lijin Zhao, Doctor, +86 13668526996, 386421696@qq.com
About this study
Official title: 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).
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).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Anlotinib hydrochloride capsules, Penpulimab injection, Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride capsules, Penpulimab injectionDrug
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).
Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placeboDrug
placebo control, no active substance.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib hydrochloride capsules + Penpulimab injection | Experimental | Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle. Receives: Drug: Anlotinib hydrochloride capsules, Penpulimab injection |
| Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo | Placebo comparator | Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle. Receives: Drug: Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 3 years.
Secondary outcomes (4)
Time to recurrence(TTR)
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.
Measured: Baseline up to 3 years.
Time to extrahepatic metastasis or macrovascular invasion
Time to extrahepatic metastasis or macrovascular invasion as assessed by the investigator.
Measured: Baseline up to 3 years.
Overall survival (OS)
OS defined as the time from the date of randomization until the date of death due to any cause.
Measured: Baseline up to 3 years.
Objective response rate (ORR) after first recurrence
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.
Measured: Baseline up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start10 May 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862337
- Sponsor's protocol ID
- ALTN-AK105-III-06
- Status last verified
- Jul 2022
- First submitted
- 15 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT05862337
- Acronym / sponsor ID
- ALTN-AK105-III-06
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib hydrochloride capsules + Penpulimab injection | Experimental | Drug: Anlotinib hydrochloride capsules, Penpulimab injectionAnlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle. |
| Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo | Placebo comparator | Drug: Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placeboAnlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib hydrochloride capsules, Penpulimab injectionAnlotinib hydrochloride capsules is a multitargeted receptor tyrosine kinase inhibitor. Penpulimab injection is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1). | Drug | Anlotinib hydrochloride capsules + Penpulimab injection |
| Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placeboplacebo control, no active substance. | Drug | Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo |
Primary outcome
Recurrence-free survival (RFS)
Time frame: 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.
4 secondary outcomes
Time to recurrence(TTR)
Time frame: Baseline up to 3 years.
Time to extrahepatic metastasis or macrovascular invasion
Time frame: Baseline up to 3 years.
Overall survival (OS)
Time frame: Baseline up to 3 years.
Objective response rate (ORR) after first recurrence
Time frame: Baseline up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib hydrochloride capsules, Penpulimab injection in people with Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 67 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: Baseline up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.