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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Gastric Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02583659

TJCC004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
2. Unresectable locally advanced, or recurrent, or metastasis disease；
3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
4. Life expectancy of at least 3 months;
5. ECOG score 0-2;
6. Voluntarily signed the informed consent.

Exclusion criteria

1. Previously treated with first-line chemotherapy;
2. First-line chemotherapy with single drug.

Trial design

250 participants in 1 patient group

Combined chemotherapy

Description:

AGC patients treated with first-line combined chemotherapy