NCT03410732

Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer

Activated Autologous Dendritic Cells by Autologous Tumor Cell Membrane Proteins in Treatment of Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: LanZhou University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. The autologous DCs are collected and enriched from peripheral blood, and then 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. All patients will be followed up for at least 2 years after treatment.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-01
• Primary completion: 2020-07-01
• Completion: 2020-12-01
• First posted: 2018-01-25
• Last updated: 2018-01-25

Locations

1 site across 1 country: China