NCT06977594

Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.

Conditions

• Ovarian Cancer
• Endometrial Cancer
• Cervical Cancer

Interventions

Type	Name	Description
OTHER	Proactive immune tolerance induction	Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
OTHER	Standard Treatment	Standard treatment throughout all chemotherapy cycles
DRUG	Paclitaxel and carboplatin	A chemotherapy regimen for gynecologic cancers.
DRUG	Standard premedication (20 mg)	Premedication includes 20 mg of dexamethasone.
DRUG	Reduced premedication (10 mg)	Premedication includes 20 mg of dexamethasone.
DRUG	Reduced premedication (5 mg)	Premedication includes 5 mg of dexamethasone.

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-05-31
• Completion: 2028-05-31
• First posted: 2025-05-18
• Last updated: 2025-06-24

Locations

1 site across 1 country: South Korea