A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
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
1 other identifier
interventional
528
1 country
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2020
Typical duration for phase_3
45 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
First Submitted
Initial submission to the registry
May 9, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 13, 2020
January 1, 2020
3.4 years
May 9, 2020
May 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
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 Outcomes (4)
Progression-free survival (PFS)
up to 45 weeks
Overall response rate (ORR)
up to 45 weeks
Disease control rate (DCR)
up to 45 weeks
Duration of response (DOR)
up to 45 weeks
Study Arms (2)
Anlotinib hydrochloride capsule + AK105 injection
EXPERIMENTALAnlotinib 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.
Standard Second-line Chemotherapy
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100038, China
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100048, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101100, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350011, China
Quanzhou First Hospital
Quanzhou, Fujian, 362000, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733000, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510610, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150040, China
AnYang Tumor Hospital
Anyang, Henan, 455000, China
Xinxiang Central Hospital
Xinxiang, Henan, 453000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nantong Cancer Hospital
Nantong, Jiangsu, 226361, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Hospital of Jiangnan University
Wuxi, Jiangsu, 214062, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Liaoning Cancar Hospital
Shenyang, Liaoning, 110042, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Tianjin Medical University General Hospital
Tianjing, Tianjing, 300050, China
Tianjin Medical University Cancer Institute and Hospital
Tianjing, Tianjing, 300060, China
The First People's Hospital of kashi region
Kashgar, XinJiang Uighur Autonomous Region, 844000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2020
First Posted
May 13, 2020
Study Start
May 20, 2020
Primary Completion
October 31, 2023
Study Completion
December 31, 2023
Last Updated
May 13, 2020
Record last verified: 2020-01