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

Primary Purpose

Gastric Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

autologous gp96 vaccination

Oxaliplatin+S-1

About this trial

This is an interventional treatment trial for Gastric Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
Able to read and understand the informed consent document, must sign the informed consent
Age: 18 to 75 years old
Availability of at least 0.5 g tumor sample
ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures
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)
Normal heart function
NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

Exclusion Criteria:

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

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

gp96 group

control group

Arm Description

autologous gp96 vaccination + basal treatment for gastric cancer

Oxaliplatin+S-1

Outcomes

Primary Outcome Measures

Disease free survival

Number of participants with adverse events related to gp96 immunotherapy

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

Changes in antigen specific T cells

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

Full Information

NCT ID

NCT02317471

First Posted

December 10, 2014

Last Updated

June 2, 2016

Sponsor

Chinese PLA General Hospital

Collaborators

Cure&Sure Biotech Co., LTD

1. Study Identification

Unique Protocol Identification Number

NCT02317471

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

Collaborators

Cure&Sure Biotech Co., LTD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gp96 group

Arm Type

Experimental

Arm Description

autologous gp96 vaccination + basal treatment for gastric cancer

Arm Title

control group

Arm Type

Other

Arm Description

Oxaliplatin+S-1

Intervention Type

Biological

Intervention Name(s)

autologous gp96 vaccination

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin+S-1

Other Intervention Name(s)

Oxaliplatin(Sanofi-aventis), S-1(Taiho)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease free survival

Time Frame

2 years

Title

Number of participants with adverse events related to gp96 immunotherapy

Description

Time Frame

participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.

Secondary Outcome Measure Information:

Title

Changes in antigen specific T cells

Description

Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

Time Frame

within 3 days before the first vaccination and within 3 days after the 10th vaccination

Title

Overall survival

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection Able to read and understand the informed consent document, must sign the informed consent Age: 18 to 75 years old Availability of at least 0.5 g tumor sample ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures 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) Normal heart function NOT participate in ANY other clinical trials within 4 weeks prior to vaccination. Exclusion Criteria: Unable to get the informed consent Female patients who are pregnant or breastfeeding Progression prior to treatment as determined by the principal investigator Transplant recipient Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection Unstable or severe intercurrent medical conditions Patient with allergic constitution Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zheng Peng, MD

Phone

086-10-66938028

zihpeng@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Chen, MD

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zheng Peng, MD

Phone

086-10-66938028

zihpeng@sina.com

First Name & Middle Initial & Last Name & Degree

Lin Chen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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