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

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

Study Overview

• Status: Unknown
• Conditions: Gastric Carcinoma
• Intervention / Treatment: Biological: autologous gp96 vaccination; Drug: Oxaliplatin+S-1

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zheng Peng, MD; Phone Number: 086-10-66938028; Email: zihpeng@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Zheng Peng, MD; Phone Number: 086-10-66938028; Email: zihpeng@sina.com
      • Principal Investigator: Lin Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival		2 years
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.	participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 3 days before the first vaccination and within 3 days after the 10th vaccination
Overall survival		3 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Cure&Sure Biotech Co., LTD
• Investigators: Principal Investigator: Lin Chen, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: PLAG-CS-Ga-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No