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

Soochow University

Status and phase: Active, not recruiting; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: Apatinib; Biological: Cytokine-Induced Killer Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02485015

CZYY-GAS-001

Details and patient eligibility

About

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.

Full 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) .

Enrollment: 80 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Apatinib alone

Other group

Description:

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.

Treatment:

Drug: Apatinib

Apatinib+CIK

Experimental group

Description:

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

Treatment:

Drug: Apatinib

Biological: Cytokine-Induced Killer Cells