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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02317471
Collaborator
Cure&Sure Biotech Co., LTD (Industry)
45
Enrollment
1
Location
2
Arms
37
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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 Names:
  • Oxaliplatin(Sanofi-aventis), S-1(Taiho)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease free survival [2 years]

    2. Number of participants with adverse events related to gp96 immunotherapy [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 [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 [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital
    • Cure&Sure Biotech Co., LTD

    Investigators

    • Principal Investigator: Lin Chen, MD, Chinese PLA General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Dec 16, 2014
    Last Update Posted:
    Jun 6, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Oxaliplatin

    Study Results

    No Results Posted as of Jun 6, 2016