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

NCT ID: NCT02485015

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2033-06-30

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) .

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib alone

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

Group Type: OTHER

Apatinib

Intervention Type: DRUG

Advanced gastric cancer patients take Apatinib 850mg qd by mouth.

Apatinib+CIK

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

Group Type: EXPERIMENTAL

Cytokine-Induced Killer Cells

Intervention Type: BIOLOGICAL

Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.

Apatinib

Intervention Type: DRUG

Advanced gastric cancer patients take Apatinib 850mg qd by mouth.

Interventions

Cytokine-Induced Killer Cells

Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.

Intervention Type: BIOLOGICAL

Apatinib

Advanced gastric cancer patients take Apatinib 850mg qd by mouth.

Intervention Type: DRUG

Other Intervention Names

CIK; YN968D1

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Changzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CZYY-GAS-001

Identifier Type: -

Identifier Source: org_study_id