A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate the safety and efficacy of apatinib combined with S1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.

Official Title
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A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, aged between 18 and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1; Failure or intolerance to at least one prior line of systemic chemotherapy regimen; Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN); Expected survival of ≥ 12 weeks. Exclusion Criteria: Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction; Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months; Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed; Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib); With psychotropic drug abuse history and can't get rid of or mental disorder patients; Associated with CNS (central nervous system) metastases; Active bacterial infections; Pregnant or breast-feeding women; Any other condition that might place the patient at undue risk or preclude a patient from completing the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib plus S1<br>patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity | Drug: Apatinib<br>* Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle<br>* Other names: S1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy | Approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | defined as the time from randomize to death | Approximately 2 years | 
| Safety (incidence of adverse events) | incidence of adverse events | Approximately 1 year | 
| Quality of life(QoL) | as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) | Approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, gastroesophageal junction cancer, Apatinib, S1