Status:
UNKNOWN
Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer
Lead Sponsor:
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborating Sponsors:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Jingzhou Central Hospital
Conditions:
Gastric Cancer
Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK) for gastric cancer.
Detailed Description
40 patients with stage Ⅰ～Ⅲ Gastric Cancer,who had received surgery and kept their tumor tissue,will be randomly divided into group A（receive Ag-D-CIK treatment and chemotherapy) or group B（just receiv...
Eligibility Criteria
Inclusion
- Patients who can accept curative operations
- 18\~80 years old
- Histologically confirmed with gastric cancer at stage Ⅰ\~Ⅲ
- Patients who can accept radical gastrectomy;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Exclusion
- Hemoglobin\<8.0 g/dL,White blood cell \<3 x 10\^9/L;Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02215837
Start Date
August 1 2014
End Date
May 1 2018
Last Update
May 24 2016
Active Locations (2)
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1
Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
Guangzhou, Guangdong, China, 510000
2
Jingzhou Central Hospital Immunotherapy center
Jingzhou, Hubei, China, 434020