Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)

Study Overview
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Brief Summary
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The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.

Official Title
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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)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Anlotinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib<br>Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Anlotinib<br>* Anlotinib p.o. qd<br>|
| Placebo Comparator: Placebo<br>Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Placebo<br>* Placebo p.o. qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From randomization until death (up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | each 42 days up to PD or death(up to 24 months) | 
| 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) |