The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

Phase 2

Active, not recruiting

• Conditions: Stomach Neoplasms
• Interventions: Biological: Cytokine-Induced Killer Cells; Drug: Apatinib

• Registration Number: NCT02485015
• Lead Sponsor: The First People's Hospital of Changzhou

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) .

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19
• Primary Completion: 2030-06
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib+CIK	Cytokine-Induced Killer Cells	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
Apatinib alone	Apatinib	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.
Apatinib+CIK	Apatinib	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	3 months

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3 months