Clinical trial NCT06977594: Proactive Immune Tolerance Induction in Chemotherapy for 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Keywords: Immune tolerance induction
Desensitization
Drug hypersensitivity
Chemotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
name: Korea Health Industry Development Institute
First posted: 2025-05-18
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo-controlled, parallel-group, open-label, clinical trial
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Hypersensitivity reaction incidence
timeFrame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).
Secondary outcomes:
measure: Chemotherapy completion rate
timeFrame: From chemotherapy initiation to the last cycle in each patient, an average of 6 months
measure: Severity of hypersensitivity reaction
timeFrame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).
measure: Patients' quality of life
timeFrame: From chemotherapy initiation to the last cycle, an average of 6 months
measure: Tumor Response Rate
timeFrame: At every third chemotherapy cycle in each patient
measure: Survival rate
timeFrame: At study completion in each patient, an average of 1 year
measure: Recurrence Rate
timeFrame: At study completion in each patient, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: