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CSC-DC Vaccine in Metastatic Ovarian Cancer
NCT02178670Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- Apr 2015
- Countries
- 1
- Sponsor
- Fuda Cancer Hospital
- Modality
- Whole Cell Cancer Vaccines, Dendritic Cell Vaccines
- Drugs
- CSC-DC vaccine
- Conditions
- ovarian cancer
01
Overview
Phase 2, randomised, open-label trial of CSC-DC vaccine in ovarian cancer (4 arms), sponsored by Fuda Cancer Hospital. Primary endpoint: Number of participants with adverse events at 3 months. Started Jun 2014; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
non-cancer stem cell vaccine
Control group receiving no cancer stem cell vaccine (Placebo)
giving low dose vaccine
Experimental group receiving low dose CSC-DC vaccine
giving middle dose vaccine
Experimental group receiving middle dose CSC-DC vaccine
giving high dose vaccine
Experimental group receiving high dose CSC-DC vaccine
03
Who it enrols
Patients with FIGO stage III epithelial ovarian cancer in remission after surgery and primary chemotherapy, age 18-75, with adequate organ function.
04
Endpoints
Primary
Number of participants with adverse events
Secondary
Vaccine immune responses to the immunizations
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