Status:
UNKNOWN
Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer
Lead Sponsor:
West China Second University Hospital
Conditions:
Recurrent Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
Effective treatments are desperately needed for ovarian cancer patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer p...
Detailed Description
This is a single arm, non-randomized phase I study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer ...
Eligibility Criteria
Inclusion
- 18-75 years old female patients；
- Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer;
- Normal liver, heart as well as kidney functions and blood chemistry;
- Predicted survival for more than 6 months；
- Provision of signed and dated informed consent form.
Exclusion
- Allergic to human albumin, an excipient of the manufactured dendric cell vaccine；
- Predicted survival for less than 6 months；
- Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus;
- Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ；
- Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline;
- Other conditions deemed unsuitable for this study by the leading investigators.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05270720
Start Date
September 1 2022
End Date
March 1 2024
Last Update
March 8 2022
Active Locations (1)
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1
west china second University， SICHUAN University, China
Chengdu, Sichuan, China, 610016