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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined chemotherapy | AGC patients treated with first-line combined chemotherapy |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotheapy-naive gastric cancer and gastroesophageal adenocarcinoma patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianglin Yuan, MD,PHD | Contact | 13667241722 | yxl@medmail.com.cn | |
| Suxian Wei, MD | Contact | 15927421058 | wsxattj@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianglin Yuan, MD,PHD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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DNA extracted from peripheral blood sample
| 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |