A Phase 2 interventional study of Apatinib mesylate tablets in Gastric Cancer, Apatinib and Biomarker, sponsored by The First Affiliated Hospital of Bengbu Medical University. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by The First Affiliated Hospital of Bengbu Medical University · Phase 2, Interventional, and Treatment
The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.
Exclusion Criteria:
take apatinib orally (500mg/d, once a day, continuously)
Drug: Apatinib mesylate tablets
Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.
Progression-free survival (PFS)
PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.
Time frame: 1 year
Overall survival (OS)
OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.
Time frame: 2 years
Disease control rate (DCR)
DCR was defined as the proportion of patients who achieved complete response (CR ), partial response (PR) and stable disease (SD) for at least 8 weeks.
Time frame: 1 year
Objective response rate (ORR)
ORR was defined as the proportion of eligible patients who achieved a confirmed CR or PR by RECIST 1.1 criteria evaluated by the investigators.
Time frame: 1 year
Quality of life score (QoL)
QoL is a questionnaire developed to assess the quality of life of cancer patients.
Time frame: 1 year
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: 1 year
Tumor biomarkers
Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling.
Time frame: Before the start of apatinib treatment
Plan to share: No
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The First Affiliated Hospital of Bengbu Medical University