Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer

Detailed Description
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from the first cycle of treatment (day one) to two month after the last cycle

Official Title
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Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: taxel plus raltitrexed
* Drug: taxol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 75 years old 2.Pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma 3.patient failed after The first line treatment of 5-Fu and platinum ,patient relapse half year after using 5 - Fu and platinum as Postoperative adjuvant chemotherapy 4.ECOG 0-1 5.At least one measurable objective tumor lesions 6.ANC≥1.5*109/L；PLT≥80*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤1.5ULN； Cr≤ULN；Ccr≥60ml/min 7.Expected survival period for 3 months or more 8. patients with voluntary participation, and sign the informed consent Exclusion Criteria: Recurrence after transfer have received taxol or docetaxel as first-line chemotherapy,If the adjuvant chemotherapy with paclitaxel,From the last chemotherapy for 6 months or less With uncontrollable large pleural or peritoneal effusion In the near future has a history of myocardial infarction (3 months) Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas; With brain metastasis Severe uncontrolled medical disease or acute infection Pregnancy or breast-feeding women Has a long history of chronic diarrhea, or now complete intestinal obstruction patients

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 |
| --- | --- |
| Experimental: Paclitaxel plus raltitrexed<br>taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle | Drug: taxel plus raltitrexed<br>* taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle<br>|
| Active Comparator: taxol<br>taxol 135 mg/m2, every three weeks for a cycle | Drug: taxol<br>* taxol 135 mg/m2, every three weeks for a cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | Since the date of random to disease progression or any cause of death，the average time is 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PFS