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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Group | Experimental | take apatinib orally (500mg/d, once a day, continuously) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib mesylate tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor biomarkers | Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling. | Before the start of apatinib treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Yang, M.D.,Ph.D | Contact | +86-552-3086178 | qiannianhupo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiong Wu, M.D.,Ph.D | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | 233004 | 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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| ID | Term |
|---|---|
| C553458 | apatinib |
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Apatinib Monotherapy
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|
| 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. | 1 year |
| Quality of life score (QoL) | QoL is a questionnaire developed to assess the quality of life of cancer patients. | 1 year |
| Adverse Events(AEs) | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. | 1 year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |