Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer
NCT03410732 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2018-01-25
Summary
Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. DCs are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc.
Conditions
Interventions
- BIOLOGICAL
-
activated DCs
autologous dendritic cells are collected and enriched from 50 ml of peripheral blood, then activated by autologous tumor cell membrane proteins. Then the activated DCs are iv infused in 21 days after a radical surgery.
- PROCEDURE
-
radical surgery only
Only radical surgery is given to the control group
Sponsors & Collaborators
-
LanZhou University
lead OTHER
Principal Investigators
-
Yumin Li · Lanzhou University Second Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-01
- Primary Completion
- 2020-07-01
- Completion
- 2020-12-01
Countries
- China
Study Locations
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