Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

Not Applicable

Not yet recruiting

• Conditions: Ovarian Cancer; Endometrial Cancer; Cervical Cancer
• Interventions: Other: Standard Treatment; Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg); Drug: Reduced premedication (5 mg); Drug: Reduced premedication (10 mg)

• Registration Number: NCT06977594
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-14
• Study First Posted: 2025-05-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Study Start: 2025-06-25
• Primary Completion: 2027-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication	Standard premedication (20 mg)	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone.
(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Standard premedication (20 mg)	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Standard Treatment	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication	Proactive immune tolerance induction	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone.
(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Standard premedication (20 mg)	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication	Paclitaxel and carboplatin	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone.
(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication	Reduced premedication (5 mg)	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone.
(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Standard Treatment	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Paclitaxel and carboplatin	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Standard premedication (20 mg)	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication	Proactive immune tolerance induction	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone.
(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication	Paclitaxel and carboplatin	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone.
(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Standard Treatment	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Paclitaxel and carboplatin	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication	Proactive immune tolerance induction	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone.
(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication	Paclitaxel and carboplatin	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone.
(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication	Reduced premedication (10 mg)	Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone.
(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication	Paclitaxel and carboplatin	Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.

Primary Outcome Measures

Name	Time	Method
Hypersensitivity reaction incidence	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).	Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases / total chemotherapy administrations) × 100.; Hypersensitivity reaction will be defined as a Grade ≥2 event according to Common Terminology Criteria for Adverse Events (CTCAE), or a moderate or higher event according to Brown's criteria.

Secondary Outcome Measures

Name	Time	Method
Patients' quality of life	From chemotherapy initiation to the last cycle, an average of 6 months	Patients' quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better outcomes for the Global Health Status and Functional Scales, whereas higher scores on the Symptom Scales indicate worse symptoms.
Tumor Response Rate	At every third chemotherapy cycle in each patient	Tumor response rate is defined as the proportion of patients who experience tumor size reduction or disappearance in response to chemotherapy. It is calculated as the proportion of patients who achieve a complete response (disappearance of all tumors with no evidence of new lesions) or a partial response (at least a 30% reduction in the size of tumors, with no appearance of new lesion) after planned chemotherapy.
Recurrence Rate	At study completion in each patient, an average of 1 year	Recurrence rate is defined as the proportion of patients who experience a return of disease after achieving a response to treatment.
Survival rate	At study completion in each patient, an average of 1 year	Survival rate is defined as the proportion of patients who remain alive, with or without disease, after completion of the planned chemotherapy.
Chemotherapy completion rate	From chemotherapy initiation to the last cycle in each patient, an average of 6 months	Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation.
Severity of hypersensitivity reaction	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).	Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of