The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- Huazhong University of Science and Technology
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Overall survival(OS) . overall survival Overall survival(OS)
- Last Updated
- 10 years ago
Overview
Brief Summary
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
1. 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. 2. Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer. 3. Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.
Investigators
Xianglin Yuan
Professor, Chief Physician
Huazhong University of Science and Technology
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall survival(OS) . overall survival Overall survival(OS)
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Secondary Outcomes
- 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)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Through first-line treatment completion,up to 24 weeks.)
- 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)