Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
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ClinicalTrials.gov Identifier: NCT02317471 |
Recruitment Status : Unknown
Verified June 2016 by Lin Chen, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : December 16, 2014
Last Update Posted : June 6, 2016
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Sponsor:
Chinese PLA General Hospital
Collaborator:
Cure&Sure Biotech Co., LTD
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | December 10, 2014 | |||
First Posted Date ICMJE | December 16, 2014 | |||
Last Update Posted Date | June 6, 2016 | |||
Study Start Date ICMJE | November 2014 | |||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96 | |||
Official Title ICMJE | Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96 | |||
Brief Summary | The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Gastric Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
45 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2017 | |||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02317471 | |||
Other Study ID Numbers ICMJE | PLAG-CS-Ga-01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Lin Chen, Chinese PLA General Hospital | |||
Study Sponsor ICMJE | Chinese PLA General Hospital | |||
Collaborators ICMJE | Cure&Sure Biotech Co., LTD | |||
Investigators ICMJE |
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PRS Account | Chinese PLA General Hospital | |||
Verification Date | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |