Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

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

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.

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.

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.