Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)
- Registration Number
- NCT02461407
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 378
- Signed and dated informed consent;
- Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
- Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
- >=18 years old；ECOG PS：0~1；Estimated life expectancy >3 months
- Main organs function is normal;
- Patients who have been treated with anlotinib previously;
- Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
- Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
- Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
- CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
- Patients with a clear tendency of gastrointestinal bleeding;
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
- Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
- Patients with any severe and/or unable to control diseases;
- Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;
- Patients with any physical signs of bleeding diathesis or medical history, no matter how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers or fractures;
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- Brain metastases patients with symptoms or symptoms controlled < 2 months;
- Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Anlotinib Anlotinib Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From randomization until death (up to 24 months)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) each 42 days up to intolerance the toxicity or PD (up to 24 months) Disease Control Rate (DCR) each 42 days up to intolerance the toxicity or PD (up to 24 months) Progress free survival (PFS) each 42 days up to PD or death(up to 24 months)
Trial Locations
- Locations (38)
The First Affiliated Hospital, Anhui Medical University
🇨🇳Hefei, Anhui, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Fourth Hospital of Hebei Medical University Tumor Hospital of Hebei Province
🇨🇳Shijiazhuang, Hebei, China
The Third Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Liaoning Province Tumor Hospital
🇨🇳Shenyang, Liaoning, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Union Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Yunnan Province Tumor Hospital
🇨🇳Kunming, Yunnan, China
Henan Province Tumor Hospital
🇨🇳Luoyan, Henan, China
The 307th Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Harbin medical university affiliated tumor hospita
🇨🇳Harbin, Heilongjiang, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Fudan University Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Shandong Tumor Hospital
🇨🇳Jinan, Shandong, China
Linyi City Tumor Hospita
🇨🇳Linyi, Shandong, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Tangdu Hospital of The fourth Military Medical University
🇨🇳Xian, Shanxi, China
Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital School of Medical,Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Lanzhou General Hospital
🇨🇳Lanzhou, Gansu, China
Chongqing Daping Hospital
🇨🇳Chongqing, Chongqing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Hunan Province Tumor Hospital
🇨🇳Changsha, Hunan, China
The General Hospital of Nanhua University
🇨🇳Hengyang, Hunan, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Nantong Cancer Hospital
🇨🇳Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China