Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
NCT02317471 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2016-06-06
Summary
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
Conditions
- Gastric Carcinoma
Interventions
- 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.
Sponsors & Collaborators
-
Cure&Sure Biotech Co., LTD
collaborator INDUSTRY -
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
Lin Chen, MD · Chinese PLA General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- China
Study Locations
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