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Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
Sponsor: Seoul National University Hospital
Summary
The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer. The main questions it aims to answer are: \- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles? Participants will: * Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment. * Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.
Official title: A Randomized, Placebo-controlled, Parallel-group, Open-label Trial to Evaluate the Efficacy of Proactive Immune Tolerance Induction to Paclitaxel and Carboplatin in Patients With Gynecologic Cancer
Key Details
Gender
FEMALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-06-25
Completion Date
2028-05-31
Last Updated
2025-06-24
Healthy Volunteers
No
Interventions
Proactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Standard Treatment
Standard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
Reduced premedication (10 mg)
Premedication includes 20 mg of dexamethasone.
Reduced premedication (5 mg)
Premedication includes 5 mg of dexamethasone.
Locations (1)
Seoul National University Hospital
Seoul, South Korea