Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer

Study Overview
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Brief Summary
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Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency. Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: S1+Docetaxel
* Drug: S1+Docetaxel followed by S1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically or cytologically confirmed gastric cancer Advanced or recurrent, metastatic disease At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) Life expectancy of at least 3 months Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks Haematopoietic and Hepatic status: Absolute neutrophil count >1.5x109/L,Platelet count > 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis) Cardiovascular: Baseline LVEF 50% measured by echocardiography Exclusion Criteria: Symptomatic brain metastasis Active or uncontrolled infection Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen History of other malignancy Pregnant or lactating women

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S1+Docetaxel<br> | Drug: S1+Docetaxel<br>* Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression<br>|
| Experimental: S1+Docetaxel followed by S1<br> | Drug: S1+Docetaxel followed by S1<br>* Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) |  | 1 year | 
| Disease control rate(DCR) |  | 1 year | 
| Overall survival(OS) |  | 3 years |