The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Detailed Description
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Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

Official Title
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A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer

Conditions
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Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases, Digestive System Neoplasms, Capecitabine, Apatinib, Neoplasms, Molecular Mechanisms of Pharmacological Action

Intervention / Treatment
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* Drug: Apatinib
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma ECOG PS 0-2 At least one measurable or evaluable lesion in the first-line chemotherapy The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD The time from the last cycle treatment to the enrollment cannot exceed 6 weeks Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN) Exclusion Criteria: Received 2 or more regimens for palliative chemotherapy Pregnant or lactating women Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction Clinically significant active bleeding, OB 2+ or higher Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia Uncontrolled significant comorbid conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib<br>In this arm, patients will receive a daily oral treatment with Apatinib 500mg. | Drug: Apatinib<br>* Apatinib: 500mg qd po, q4w<br>|
| Experimental: Capecitabine<br>In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks. | Drug: Capecitabine<br>* Capecitabine: 1000mg/m2 bid po, d1-14, q3w<br>|
| No Intervention: Observation<br>In this arm, no additional treatment will be given, and patients will be followed up at regular time | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | PFS is calculated from the time of randmization to disease progression or death whichever happen first | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is calculated from the time of randmization to death | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capecitabine, Apatinib, Maintenance Treatment, Advance Gastric Cancer