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Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96

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ClinicalTrials.gov Identifier: NCT02317471
Recruitment Status : Unknown
Verified June 2016 by Lin Chen, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : December 16, 2014
Last Update Posted : June 6, 2016
Sponsor:
Collaborator:
Cure&Sure Biotech Co., LTD
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Carcinoma Biological: autologous gp96 vaccination Drug: Oxaliplatin+S-1 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
Study Start Date : November 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: gp96 group
autologous gp96 vaccination + basal treatment for gastric cancer
 Biological: autologous gp96 vaccination

Vaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery.

gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion.


Drug: Oxaliplatin+S-1

Treatment will be start at the 5th week after the surgery.

S-1: 40~60mg bid，d1~14 q3W; oxaliplatin:130mg/m2，iv drip for 2h，d1,q3W 6 cycles.

Other Name: Oxaliplatin(Sanofi-aventis), S-1(Taiho)
control group
Oxaliplatin+S-1
 Drug: Oxaliplatin+S-1

Treatment will be start at the 5th week after the surgery.

S-1: 40~60mg bid，d1~14 q3W; oxaliplatin:130mg/m2，iv drip for 2h，d1,q3W 6 cycles.

Other Name: Oxaliplatin(Sanofi-aventis), S-1(Taiho)


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 2 years ]
  2. Number of participants with adverse events related to gp96 immunotherapy [ Time Frame: participants will be followed from the day of the first vaccination to the 30th day after the last vaccination. ]

    A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.

    And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 3.0 criteria.



Secondary Outcome Measures :
  1. Changes in antigen specific T cells [ Time Frame: within 3 days before the first vaccination and within 3 days after the 10th vaccination ]
    Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

  2. Overall survival [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
  2. Able to read and understand the informed consent document, must sign the informed consent
  3. Age: 18 to 75 years old
  4. Availability of at least 0.5 g tumor sample
  5. ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures
  6. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] and bilirubin (total) <1.5 times IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs)
  7. Normal heart function
  8. NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

Exclusion Criteria:

  1. Unable to get the informed consent
  2. Female patients who are pregnant or breastfeeding
  3. Progression prior to treatment as determined by the principal investigator
  4. Transplant recipient
  5. Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection
  6. Unstable or severe intercurrent medical conditions
  7. Patient with allergic constitution
  8. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
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): NCT02317471


Contacts
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Contact: Zheng Peng, MD 086-10-66938028 zihpeng@sina.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Zheng Peng, MD    086-10-66938028    zihpeng@sina.com   
Principal Investigator: Lin Chen, MD         
Sponsors and Collaborators
Chinese PLA General Hospital
Cure&Sure Biotech Co., LTD
Investigators
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Principal Investigator: Lin Chen, MD Chinese PLA General Hospital
More Information
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Responsible Party: Lin Chen, Director of the general surgery department, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02317471    
Other Study ID Numbers: PLAG-CS-Ga-01
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents