A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Study Overview
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Brief Summary
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The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.

Official Title
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Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study

Conditions
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Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Drug: ApatinibTablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to75 years old; Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction); Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens; ECOG PS of 0-2; Major organ function has to meet the following criteria: For results of blood routine test (without blood transfusion within 14 days): HB ≥ 90g / L ANC ≥ 1.5 × 109 / L PLT ≥ 80 × 109 / L Biochemical tests results: Bilirubin <1.25 times the upper limit of normal (ULN) ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula) An expected survival of ≥ 3 months; Patient received apatinib treatment regimen at investigators' discretion; Patient has to voluntarily join the study and sign the Informed Consent Form for the study; Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug. Exclusion Criteria: Subjects with uncontrolled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), as well as Grade ≥ 2 cardiac dysfunction; Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding; Abnormal coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleeding; Presence of central nervous system metastases; Pregnant or lactating women; Other conditions regimented at investigators' discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Interventional Model Description: A large-scale single-arm phase IV study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Apatinib Tablets | Drug: ApatinibTablets<br>* Apatinib Tablets, recommended dose of 850mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, which was assessed by recording the incidence and severity of adverse events |  | between first dose of apatinib and up to 30 days after the last dose of apatinib | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Event driven, an expected average of 34 weeks | 
| Progression Free Survival |  | An expected average of 12 weeks | 
| Objective Response Rate |  | An expected average of 12 weeks | 
| Disease Control Rate |  | An expected average of 12 weeks | 
| Quality of life, measured by the questionnaire of EORTC QLQ-C30 |  | Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, Metastatic