Clinical trial NCT04385550: A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-13
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&gt; 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 45 weeks
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 45 weeks
measure: Overall response rate (ORR)
timeFrame: up to 45 weeks
measure: Disease control rate (DCR)
timeFrame: up to 45 weeks
measure: Duration of response (DOR)
timeFrame: up to 45 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Shijitan Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: The Sixth Medical Center of PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Wuwei
country: China
facility: Gansu Wuwei Tumour Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi Zhuang Autonomous Region
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: AnYang Tumor Hospital
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Cancer Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Hospital of Jiangnan University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancar Hospital
state: Liaoning
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia Hui Autonomous Region
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjing
country: China
facility: Tianjin Medical University General Hospital
state: Tianjing
city: Tianjing
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjing
city: Kashi
country: China
facility: The First People's Hospital of kashi region
state: XinJiang Uighur Autonomous Region
Study officials:
References: