Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer
NCT05270720 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2022-03-08
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 patients. Secondary outcomes will be evaluated such as patient pharmacodynamics, progression-free survival and overall survival.
Conditions
- Recurrent Ovarian Cancer
Interventions
- BIOLOGICAL
-
dendritic cell
Biological: Dendritic Cell Immunotherapy Adult patients with histopathologically diagnosed Ovarian Cancer will be eligible for this novel, personalized dendritic cell vaccine during course of standard of care chemotherapy. If unacceptable side effects are observed at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive a de-escalated total dendritic cell dose of 2.5x106. If no unacceptable side effects are identified at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive an escalated total dendritic cell dose of 1X107.
Sponsors & Collaborators
-
West China Second University Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2023-09-01
- Completion
- 2024-03-01
Countries
- China
Study Locations
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