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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gastric Carcinoma

Treatments: Drug: Oxaliplatin+S-1; Biological: autologous gp96 vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02317471

PLAG-CS-Ga-01

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

gp96 group

Experimental group

Description:

autologous gp96 vaccination + basal treatment for gastric cancer

Treatment:

Drug: Oxaliplatin+S-1

Biological: autologous gp96 vaccination

control group

Other group

Description:

Oxaliplatin+S-1

Treatment:

Drug: Oxaliplatin+S-1