Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions
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Apatinib, Gastric Cancer, Biomarker

Intervention / Treatment
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* Drug: Apatinib mesylate tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma; Age ≥ 65 years; ECOG Performance Status: 0-2; No previous anti-cancer therapy for the locally advanced or metastatic disease; Unable or unwilling to chemotherapy; At least one measurable lesion as defined by RECIST 1.1; With acceptable hematologic, cardiac, hepatic, pulmonary and renal function; Can take apatinib orally; Life Expectancy: 3 months or more. Exclusion Criteria: History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ); Patients with un-controlled blood pressure on medication (> 140/90 mmHg); Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases; Patients with bleeding tendency, receiving thrombolytics or anticoagulants； Patients with massive hydrothorax or ascites; Patients with uncontrolled central nervous system (CNS) metastases; Proteinuria 2+ or 24-hour urinary protein ≥ 1g; History of drug addiction or abuse; Patients cannot take apatinib orally for any reason; Estimated life expectancy ˂ 3 months; Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials; Inability to understand and agree to informed consent.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Apatinib Monotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib Group<br>take apatinib orally (500mg/d, once a day, continuously) | Drug: Apatinib mesylate tablets<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |