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Brief Title: A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Official Title: Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study
Study ID: NCT02426034
Brief Summary: The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nanjin Military 81 Hosiptal, Nanjing, Jiangsu, China
Fudan University cancer hospital, Shanghai, Shanghai, China
Name: Jin Li, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR