A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

Recruitment & Eligibility

Inclusion Criteria

Adult patients, aged ≥18 years;
Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
Life expectancy of more than 3 months;
Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 109/L, neutrophil ≥1.5 × 109/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);

Exclusion Criteria

Pregnant or lactating women;
History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); Uncontrolled hypertension;
Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
Urine protein>grade 1;
Any factors that influence the usage of oral administration;
patients with a clear tendency of gastrointestinal bleeding;
Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
Abuse of alcohol or drugs;
Less than 4 weeks from the last clinical trial;
Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
Evidence of central nervous system(CNS) metastasis;
Disability of serious uncontrolled intercurrence infection.

Study & Design

Arm && Interventions

Group	Intervention	Description
apatinib	apatinib	Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Docetaxel	Docetaxel	Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Approximately 1 year	defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Approximately 3 years	defined as the time from randomize to death
Objective response rate (ORR)	Approximately 1 year	defined as the rate of complete response and partial response according to RECIST guidelines.
Disease control rate(DCR)	Approximately 1 year	defined as the rate of complete response , partial response and stable disease according to RECIST guidelines.
Quality of life(QoL)	Approximately 3 years	as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Safety (incidence of adverse events)	Approximately 1 year	incidence of adverse events

Recruitment & Eligibility