The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study

Study Overview
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Brief Summary
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This prospective cohort study aims to observe the efficacy and safety of the first-line combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.

Detailed Description
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Establish a clinical database for the advanced gastric cancer patients treated with first-line combined chemotherapy in Tongji hospital. 1.1.Data including age, gender, smoking state, karnofsky performance score（KPS）, disease history, clinical stage, primary tumor site, metastasis site, surgery, first-line chemotherapy, therapy after failure of first-line treatment, radiotherapy, toxicity, survival time, the time of free of progress, response were collected. 1.2.The peripheral blood samples were collected for further biomarker reserch. Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer. Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.

Official Title
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The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study

Conditions
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Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma; Unresectable locally advanced, or recurrent, or metastasis disease； Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed. Life expectancy of at least 3 months; ECOG score 0-2; Voluntarily signed the informed consent. Exclusion criteria: Previously treated with first-line chemotherapy; First-line chemotherapy with single drug.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combined chemotherapy<br>AGC patients treated with first-line combined chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) . overall survival Overall survival(OS) |  | From date of enrollment until the date of death from any cause, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) |  | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | 
| Objective response rate(ORR) |  | The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first-line treatment completion, up to 1 year | 
| Disease control rate(DCR) |  | The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | Through first-line treatment completion,up to 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, First-line chemotherapy, Biomarker