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Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

NCT06977594 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Seoul National University Boramae Hospital

    collaborator OTHER

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2027-05-31
Completion
2028-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06977594 on ClinicalTrials.gov