Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

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.

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

Primary outcomes

• 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 outcomes

• 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).
• 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.
• 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.
• 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.

Sex: Female, ages: 19 Years to any

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.