NCT02461407Unknown2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Gastric Cancer(ALTER0503)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 378
- 试验地点
- 38
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
研究组 & 干预措施
Anlotinib
Experimental
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
Placebo
Placebo Comparator
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization until death (up to 24 months)
次要结局
- 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))
研究者
研究点 (38)
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