- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385550
A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
May 9, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Randomized, Open-label, Controlled, Multicenter Phase III Study of Hydrochloride Capsule Combined With AK105 Injection Versus Standard Second-line Chemotherapy for Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy.
Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or standard second-line chemotherapy, with 1:1 random ratio.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
528
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruihua Xu
- Phone Number: 020-87343468
- Email: ruihxu@163.com
Study Locations
-
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Anhui
-
Hefei, Anhui, China, 230022
- The First Affiliated Hospital of Anhui Medical University
-
Contact:
- Kangsheng Gu, doctor
-
Principal Investigator:
- Kangsheng Gu, Doctor
-
-
Beijing
-
Beijing, Beijing, China, 100144
- Peking University Shougang Hospital
-
Contact:
- Delin Wang
- Email: dlwang163@sohu.com
-
Principal Investigator:
- Delin Wang
-
Beijing, Beijing, China, 102218
- Beijing Tsinghua Changgung Hospital
-
Contact:
- Zhuo Yu, Doctor
- Email: yuzhuo@vip.sina.com
-
Principal Investigator:
- Zhuo Yu, Doctor
-
Beijing, Beijing, China, 100038
- Beijing Shijitan Hospital Affiliated to Capital Medical University
-
Contact:
- Jirun Peng, Doctor
- Email: 1446316766@qq.com
-
Principal Investigator:
- Jirun Peng, Doctor
-
Beijing, Beijing, China, 100048
- The Sixth Medical Center of PLA General Hospital
-
Contact:
- Xinhong Zhang, Doctor
- Email: zhangxh1970@sina.com
-
Principal Investigator:
- Xinhong Zhang, Doctor
-
Beijing, Beijing, China, 101100
- Beijing Luhe Hospital Capital Medical University
-
Contact:
- Dong Yan, Doctor
- Email: yd15yt88@163.com
-
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Fujian
-
Fuzhou, Fujian, China, 350011
- Fujian Provincial Cancer Hospital
-
Contact:
- Zengqing Guo
-
Principal Investigator:
- Zengqing Guo
-
Quanzhou, Fujian, China, 362000
- Quanzhou First Hospital
-
Contact:
- Peiling Xin
- Email: xinpeiling62@126.com
-
Principal Investigator:
- Peiling Xin
-
Quanzhou, Fujian, China, 362000
- The Second Affiliated Hospital of Fujian Medical University
-
Contact:
- Tianwen Xu, Doctor
- Email: xutianwen53@163.com
-
Principal Investigator:
- Tianwen Xu, Doctor
-
Xiamen, Fujian, China, 361003
- The First Affiliated Hospital of Xiamen University
-
Contact:
- Jiayi Li
- Email: ljy778848@qq.com
-
Principal Investigator:
- Jiayi Li
-
Xiamen, Fujian, China, 361004
- Zhongshan Hospital Xiamen University
-
Contact:
- Zhijie Ding, Doctor
- Email: zhijieding@sina.com
-
Principal Investigator:
- Zhijie Ding, Doctor
-
-
Gansu
-
Lanzhou, Gansu, China, 730000
- The First Hospital of Lanzhou University
-
Contact:
- Xiaoming Hou, Doctor
- Email: 1795950416@qq.com
-
Principal Investigator:
- Xiaoming Hou, Doctor
-
Wuwei, Gansu, China, 733000
- Gansu Wuwei Tumour Hospital
-
Contact:
- Linzhi Lu
- Email: lulinzh12006@163.com
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Principal Investigator:
- Linzhi Lu
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Sun Yat-Sen University Cancer Center
-
Contact:
- Ruihua Xu, Doctor
- Email: ruihxu@163.com
-
Principal Investigator:
- Ruihua Xu, doctor
-
Guangzhou, Guangdong, China, 510610
- The Sixth Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Yanhong Deng, Doctor
-
Principal Investigator:
- Yanhong Deng, Doctor
-
Zhanjiang, Guangdong, China, 524000
- Affiliated Hospital of Guangdong Medical University
-
Contact:
- Zhong Xie
- Email: xiexieg@126.com
-
Principal Investigator:
- Zhong Xie
-
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Guangxi Zhuang Autonomous Region
-
Nanning, Guangxi Zhuang Autonomous Region, China, 530021
- Guangxi Medical University Affiliated Tumor Hospital
-
Contact:
- Jiansi Chen
- Email: wcwk0771@126.com
-
Principal Investigator:
- Jiansi Chen
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050010
- The Fourth Hospital of Hebei Medical University
-
Principal Investigator:
- Da Jiang
-
Contact:
- Da Jiang
- Email: jiangda139@163.com
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150040
- Harbin Medical University Cancer Hospital
-
Principal Investigator:
- Yanqiao Zhang, Doctor
-
Contact:
- Yanqiao Zhang, Doctor
- Email: yanqiaozhang@126.com
-
-
Henan
-
Anyang, Henan, China, 455000
- Anyang Tumor Hospital
-
Contact:
- Tao Wu
- Email: wuren909@163.com
-
Xinxiang, Henan, China, 453000
- Xinxiang Central Hospital
-
Contact:
- Guifang Zhang
- Email: xxchzhangguifang@126.com
-
Principal Investigator:
- Guifang Zhang
-
Zhengzhou, Henan, China, 450008
- Henan cancer hospital
-
Contact:
- Huijuan Wu
-
Principal Investigator:
- Huijuan Wu
-
Zhengzhou, Henan, China, 450003
- The First Affiliated Hospital of Zhengzhou University
-
Contact:
- Yanru Qin, Doctor
- Email: yanruqin@163.com
-
Principal Investigator:
- Yanru Qin, Doctor
-
-
Hubei
-
Wuhan, Hubei, China, 430079
- Hubei Cancer Hospital
-
Principal Investigator:
- Xinjun Liang, Doctor
-
Contact:
- Xinjun Liang, Doctor
- Email: doctorlxj@163.com
-
Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
Contact:
- Xianglin Yuan, Doctor
- Email: xlyuan1020@163.com
-
Principal Investigator:
- Xianglin Yuan, Doctor
-
Wuhan, Hubei, China, 430022
- Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
-
Contact:
- Tao Zhang, Doctor
- Email: 1277577866@qq.com
-
Principal Investigator:
- Tao Zhang, Doctor
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
-
Principal Investigator:
- Shanzhi Gu
-
Contact:
- Shanzhi Gu
- Email: 105575191@qq.com
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Changsha, Hunan, China, 410008
- Xiangya Hospital Central South University
-
Contact:
- Shan Zeng, Doctor
- Email: Shanzeng2012@163.com
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Principal Investigator:
- Shan Zeng, Doctor
-
Changsha, Hunan, China, 410011
- The second Xiangya Hospital of Central South University
-
Contact:
- Hongliang Yao, Doctor
- Email: yaohl0326@163.com
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Principal Investigator:
- Hongliang Yao, Doctor
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
-
Contact:
- Lingjun Zhu, Doctor
-
Principal Investigator:
- Lingjun Zhu, Doctor
-
Nanjing, Jiangsu, China, 210009
- Jiangsu Cancer Hospital
-
Contact:
- Jianwei Lu, Doctor
- Email: lujw@medmail.com.cn
-
Principal Investigator:
- Jianwei Lu, Doctor
-
Nantong, Jiangsu, China, 226361
- Nantong Cancer Hospital
-
Contact:
- Jianhong Wang
- Email: ywk_wjh@163.com
-
Principal Investigator:
- Jianhong Wang
-
Wuxi, Jiangsu, China, 214023
- Wuxi People's Hospital
-
Contact:
- Chaoying Liu
- Email: chyliu666@163.com
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Principal Investigator:
- Chaoying Liu
-
Wuxi, Jiangsu, China, 214062
- Hospital of Jiangnan University
-
Contact:
- Yong Mao, Doctor
- Email: mydoctorwx@aliyun.com
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Principal Investigator:
- Yong Mao, Doctor
-
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital of NanChang University
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Principal Investigator:
- Junhe Li, Doctor
-
Contact:
- Junhe Li, Doctor
- Email: mailto:lijunhe88@163.com
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Liaoning
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Shenyang, Liaoning, China, 110042
- Liaoning Cancar Hospital
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Contact:
- Baoli Qin, Doctor
- Email: poryqin@126.com
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Principal Investigator:
- Baoli Qin, doctor
-
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Ningxia Hui Autonomous Region
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Yinchuan, Ningxia Hui Autonomous Region, China, 750021
- People's Hospital of Ningxia Hui Autonomous Region
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Contact:
- Qingxin Zhuang
- Email: zhuangtse@163.com
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Principal Investigator:
- Qingxin Zhuang
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Shandong
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Jinan, Shandong, China, 250117
- Shandong Cancer Hospital
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Contact:
- Changzheng Li
- Email: liczdoc@163.com
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Principal Investigator:
- Changzheng Li
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Shanghai
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Shanghai, Shanghai, China, 200080
- Shanghai General Hospital
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Contact:
- Qi Li, Doctor
- Email: leeqi2001@hotmail.com
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Principal Investigator:
- Qi Li, Doctor
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Shanxi
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Taiyuan, Shanxi, China, 030013
- Shanxi Provincial Cancer Hospital
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Contact:
- Yusheng Wang, Doctor
- Email: wangyusheng1972@163.com
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Principal Investigator:
- Yusheng Wang, Doctor
-
Xi'an, Shanxi, China, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- Xi Chen, Doctor
- Email: 2002chenxi@163.com
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Principal Investigator:
- Xi Chen, Doctor
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Xi'an, Shanxi, China, 710061
- First Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- Enxiao Li, Doctor
- Email: doclienxiao@sina.com
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Principal Investigator:
- Enxiao Li, Doctor
-
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Tianjing
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Tianjing, Tianjing, China, 300050
- Tianjin Medical University General Hospital
-
Principal Investigator:
- Diansheng Zhong, Doctor
-
Contact:
- Diansheng Zhong, Doctor
- Email: zhongdsh@hotmail.com
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Tianjing, Tianjing, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Contact:
- Yi Ba, Doctor
- Email: yiba99@yahoo.com
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Principal Investigator:
- Yi Ba, doctor
-
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XinJiang Uighur Autonomous Region
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Kashi, XinJiang Uighur Autonomous Region, China, 844000
- The First People's Hospital of kashi region
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Contact:
- Wei Wang
- Email: 271865348@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. Understood and signed an informed consent form; 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months; 3. Histopathology or cytology confirmed as metastatic or local advanced gastric and gastro-oesophageal junction adenocarcinoma; 4. First-line standard chemotherapy regimen in patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment failure; 5. Has at least one measurable lesion; 6. Weight ≥40 kg or BMI ≥18.5; 7. Adequate organ function; 8. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
Exclusion Criteria:
- 1. Histopathology confirmed as squamous cell carcinoma, carcinoid, undifferentiated carcinoma, or other gastric cancer; 2. HER2 positive; 3. Has received paclitaxel or docetaxel in the first-line treatment; 4. Has received paclitaxel or docetaxel in the neoadjuvant or adjuvant treatment regimen and have relapsed or metastasized within 6 months after the last dose; 5. Has other malignant tumors within 5 years; 6. Has used anti-angiogenic drugs such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab, or related immunotherapy drugs for PD-1, PD-L1, etc; 7. Severe hypersensitivity after administration of other monoclonal antibodies; 8. Has spinal cord compression, cancerous meningitis and symptomatic brain metastasis; 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received radiotherapy, chemotherapy and surgery within 4 weeks before the first dose; 11. Has gastrointestinal bleeding tendency within 4 weeks before the first dose; 12. The tumor has invaded important blood vessels and will cause fatal bleeding; 13. Has multiple factors affecting oral medication; 14. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 15. Has any active autoimmune disease or history of autoimmune disease; 16. Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration; 17. Has any serious and / or uncontrolled disease; 18. Has active viral infection; 19. Has participated in other anticancer drug clinical trials within 4 weeks; 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib hydrochloride capsule + AK105 injection
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) plus AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.
|
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.
|
Active Comparator: Standard Second-line Chemotherapy
Participants receive 80 mg/m² IV paclitaxel on Days 1, 8 and 15 of each 28-day cycle, or 75mg/m² docetaxel every 3 weeks of each 21-day cycle until disease progression or unacceptable toxicity.
|
Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.
Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: up to 45 weeks
|
OS defined as the time from randomization to death from any cause.
Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
|
up to 45 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: up to 45 weeks
|
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
|
up to 45 weeks
|
Overall response rate (ORR)
Time Frame: up to 45 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR).
|
up to 45 weeks
|
Disease control rate (DCR)
Time Frame: up to 45 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
|
up to 45 weeks
|
Duration of response (DOR)
Time Frame: up to 45 weeks
|
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
|
up to 45 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2020
Primary Completion (Anticipated)
October 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
May 9, 2020
First Submitted That Met QC Criteria
May 9, 2020
First Posted (Actual)
May 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 13, 2020
Last Update Submitted That Met QC Criteria
May 9, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTN-AK05-III-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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