This trial is active, not recruiting.

Condition stomach neoplasms
Treatments cytokine-induced killer cells, apatinib
Phase phase 2
Targets VEGF, KIT
Sponsor The First People's Hospital of Changzhou
Start date June 2015
End date June 2030
Trial size 80 participants
Trial identifier NCT02485015, CZYY-GAS-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.
apatinib YN968D1
Advanced gastric cancer patients take Apatinib 850mg qd by mouth.
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
cytokine-induced killer cells CIK
Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.
apatinib YN968D1
Advanced gastric cancer patients take Apatinib 850mg qd by mouth.

Primary Outcomes

Overall Survival(OS)
time frame: 3 months

Secondary Outcomes

Disease-free survival
time frame: 3 months

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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.

Additional Information

Official title The Randomized, Controlled, Multicenter Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
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) .
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.