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Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215837
Recruitment Status : Unknown
Verified November 2015 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : May 24, 2016
Sponsor:
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Jingzhou Central Hospital
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Drug: Chemotherapy Biological: Ag-D-CIK Phase 2

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 receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of Ag-D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized,Controlled,Multicenter Study of Autologous Tumor Lysate-pulsed Dendritic and Cytokine-induced Killer Cells(Ag-D-CIK) Combined With Chemotherapy for Gastric Cancer.
Study Start Date : August 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Chemotherapy
After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.
 Drug: Chemotherapy
Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
Other Name: FOLFOX
Experimental: Ag-D-CIK
After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
 Drug: Chemotherapy
Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
Other Name: FOLFOX

Biological: Ag-D-CIK
8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.


Outcome Measures
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Primary Outcome Measures :
  1. Progress-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Quality of life (QOL) [ Time Frame: 3 years ]
  3. Phenotypic analysis of T cells [ Time Frame: 1 years ]
    The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

  4. Severity of adverse events [ Time Frame: 1 years ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215837


Locations
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China, Guangdong
Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
Guangzhou, Guangdong, China, 510000
China, Hubei
Jingzhou Central Hospital Immunotherapy center
Jingzhou, Hubei, China, 434020
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Jingzhou Central Hospital
Investigators
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Principal Investigator: Hai Y Liu, Professor Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center
More Information
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Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02215837    
Other Study ID Numbers: HYK-Gastric Cancer
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
Gastric cancer
D-CIK
Autologous tumor lysate
Additional relevant MeSH terms:
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Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Gastrointestinal Diseases
Digestive System Diseases
Neoplasms by Site
Stomach Diseases