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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
528

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 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:
        • Principal Investigator:
          • Delin Wang
      • Beijing, Beijing, China, 102218
        • Beijing Tsinghua Changgung Hospital
        • Contact:
        • Principal Investigator:
          • Zhuo Yu, Doctor
      • Beijing, Beijing, China, 100038
        • Beijing Shijitan Hospital Affiliated to Capital Medical University
        • Contact:
        • Principal Investigator:
          • Jirun Peng, Doctor
      • Beijing, Beijing, China, 100048
        • The Sixth Medical Center of PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Xinhong Zhang, Doctor
      • Beijing, Beijing, China, 101100
        • Beijing Luhe Hospital Capital Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Fujian Provincial Cancer Hospital
        • Contact:
          • Zengqing Guo
        • Principal Investigator:
          • Zengqing Guo
      • Quanzhou, Fujian, China, 362000
        • Quanzhou First Hospital
        • Contact:
        • Principal Investigator:
          • Peiling Xin
      • Quanzhou, Fujian, China, 362000
        • The Second Affiliated Hospital of Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Tianwen Xu, Doctor
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • Jiayi Li
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University
        • Contact:
        • Principal Investigator:
          • Zhijie Ding, Doctor
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Xiaoming Hou, Doctor
      • Wuwei, Gansu, China, 733000
        • Gansu Wuwei Tumour Hospital
        • Contact:
        • Principal Investigator:
          • Linzhi Lu
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • 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:
        • Principal Investigator:
          • Zhong Xie
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China, 530021
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Jiansi Chen
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Da Jiang
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yanqiao Zhang, Doctor
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
      • Xinxiang, Henan, China, 453000
        • Xinxiang Central Hospital
        • Contact:
        • 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:
        • Principal Investigator:
          • Yanru Qin, Doctor
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
        • Principal Investigator:
          • Xinjun Liang, Doctor
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
        • Contact:
        • Principal Investigator:
          • Xianglin Yuan, Doctor
      • Wuhan, Hubei, China, 430022
        • Union Hospital，Tongji Medical College，Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Tao Zhang, Doctor
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Shanzhi Gu
        • Contact:
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
        • Contact:
        • Principal Investigator:
          • Shan Zeng, Doctor
      • Changsha, Hunan, China, 410011
        • The second Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Hongliang Yao, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
        • Contact:
          • Lingjun Zhu, Doctor
        • Principal Investigator:
          • Lingjun Zhu, Doctor
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jianwei Lu, Doctor
      • Nantong, Jiangsu, China, 226361
        • Nantong Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jianhong Wang
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
        • Contact:
        • Principal Investigator:
          • Chaoying Liu
      • Wuxi, Jiangsu, China, 214062
        • Hospital of Jiangnan University
        • Contact:
        • Principal Investigator:
          • Yong Mao, Doctor
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Junhe Li, Doctor
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancar Hospital
        • Contact:
        • Principal Investigator:
          • Baoli Qin, doctor
    • Ningxia Hui Autonomous Region
      • Yinchuan, Ningxia Hui Autonomous Region, China, 750021
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
        • Principal Investigator:
          • Qingxin Zhuang
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Changzheng Li
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital
        • Contact:
        • Principal Investigator:
          • Qi Li, Doctor
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yusheng Wang, Doctor
      • Xi'an, Shanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Principal Investigator:
          • Xi Chen, Doctor
      • Xi'an, Shanxi, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
        • Principal Investigator:
          • Enxiao Li, Doctor
    • Tianjing
      • Tianjing, Tianjing, China, 300050
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Diansheng Zhong, Doctor
        • Contact:
      • Tianjing, Tianjing, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Principal Investigator:
          • Yi Ba, doctor
    • XinJiang Uighur Autonomous Region
      • Kashi, XinJiang Uighur Autonomous Region, China, 844000
        • The First People's Hospital of kashi region
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Anlotinib hydrochloride capsule
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).
Drug: AK105 injection
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.
Drug: Paclitaxel injection
Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.
Drug: Docetaxel injection
Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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