Proactive immune tolerance for chemo in gynecologic cancer
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
Run by Seoul National University Hospital · NCT06977594 · Data updated 2026-11-12
This trial tests whether starting a proactive immune tolerance induction during the first three cycles of paclitaxel and carboplatin can reduce hypersensitivity reactions in later cycles for women with gynecologic cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | May 21, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT06977594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 19 years or older with gynecologic cancers receiving paclitaxel and carboplatin who have no prior hypersensitivity to these drugs and can provide informed consent.
✕Probably not a fit
Patients with preexisting hypersensitivity history or conditions precluding desensitization may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates proactively desensitizing patients who are about to receive paclitaxel and carboplatin for ovarian, endometrial, or cervical cancer. Participants are randomized to either an immune tolerance induction protocol or standard treatment during the initial three cycles, followed by all patients continuing with standard chemotherapy. The tolerance induction uses an automated infusion protocol similar to conventional desensitization but aimed at preventing sensitization in patients with no prior hypersensitivity history, with possible adjustments to dexamethasone premedication. Outcomes focus on the incidence of hypersensitivity reactions in later cycles and overall feasibility of the desensitization approach.
Why it matters
Potential benefit: If successful, this approach could reduce chemotherapy-related hypersensitivity and allow more patients to complete planned treatment.
How similar studies have gone: Desensitization strategies are established for hypersensitive patients, but applying proactive tolerance induction in patients without prior reactions is novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies. * Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin. * Patients who are able to read and voluntarily provide written informed consent. * Aged 19 years or older. Exclusion Criteria: * Patients who do not wish to participate in this study voluntarily. * Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
Where it's running
-
Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hye-Ryun Kang, MD, PhD
- Email: helenmed@snu.ac.kr
- Phone: +82-2-2072-0820
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.