The Randomized, Controlled, Multicenter Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Apatinib
- Conditions
- Stomach Neoplasms
- Sponsor
- The First People's Hospital of Changzhou
- Enrollment
- 80
- Primary Endpoint
- Overall Survival(OS)
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.
Detailed Description
400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who can accept curative operations 18-70 years old
- •Histologically confirmed with gastric cancer at stage Ⅳ
- •Patients who can accept oral drugs;
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Exclusion Criteria
- •Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Pregnant or lactating patients
- •Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- •Patients who are suffering from serious autoimmune disease
- •Patients who had used long time or are using immunosuppressant
- •Patients who had active infection
- •Patients who are suffering from serious organ dysfunction
- •Patients who are suffering from other cancer
- •Other situations that the researchers considered unsuitable for this study.
Arms & Interventions
Apatinib alone
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.
Intervention: Apatinib
Apatinib+CIK
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
Intervention: Cytokine-Induced Killer Cells
Apatinib+CIK
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
Intervention: Apatinib
Outcomes
Primary Outcomes
Overall Survival(OS)
Time Frame: 3 months
Secondary Outcomes
- Disease-free survival(3 months)