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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

Tracking Information
First Submitted Date  ICMJE December 10, 2014
First Posted Date  ICMJE December 16, 2014
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • Disease free survival [ Time Frame: 2 years ]
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • Disease free survival [ Time Frame: 2 years ]
  • 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 and electrocardiogram 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • 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.
  • Overall survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
Official Title  ICMJE Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Carcinoma
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: gp96 group
    autologous gp96 vaccination + basal treatment for gastric cancer
    Interventions:
    • Biological: autologous gp96 vaccination
    • Drug: Oxaliplatin+S-1
  • control group
    Oxaliplatin+S-1
    Intervention: Drug: Oxaliplatin+S-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 15, 2014)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02317471
Other Study ID Numbers  ICMJE PLAG-CS-Ga-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lin Chen, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Cure&Sure Biotech Co., LTD
Investigators  ICMJE
Principal Investigator: Lin Chen, MD Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP