The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer

Study Overview
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Brief Summary
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To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

Official Title
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Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Oxaliplatin and Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old male or female Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ; ECOG performance status score 0-2 ; Expected survival time more than three months ; Adequate hematologic parameters and liver and kidney function ; Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L; Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ; Renal : serum creatinine ≤ ULN ; Informed consent of patients or their agents , and signed informed consent. Exclusion Criteria: For patients allergic to capecitabine ; Patients with CNS metastases Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ; Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ; Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ; Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ; The researchers believe that this test is not suitable for those who participate .

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance. | Drug: Paclitaxel<br> <br> Drug: Oxaliplatin and Capecitabine<br>* Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.<br>|
| Placebo Comparator: B<br>Observation until progression | Drug: Paclitaxel<br> <br> Drug: Oxaliplatin and Capecitabine<br>* Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | from the date of randomization until death from any cause or up to 1 year | 
| adverse events (AE) |  | from date of randomization to 28 days after the last chemo dosage | 
| health-related quality of life (HRQOL |  | evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage |