Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

Seoul National University

Status: Not yet enrolling

Conditions: Endometrial Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: Reduced premedication (10 mg); Other: Standard Treatment; Other: Proactive immune tolerance induction; Drug: Reduced premedication (5 mg); Drug: Standard premedication (20 mg); Drug: Paclitaxel and carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06977594

PINTO_C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 6 patient groups

(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel and carboplatin

Drug: Standard premedication (20 mg)

Other: Proactive immune tolerance induction

(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication

Active Comparator group

Description:

Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.

Treatment:

Drug: Paclitaxel and carboplatin

Drug: Standard premedication (20 mg)

Other: Standard Treatment

(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel and carboplatin

Other: Proactive immune tolerance induction

Drug: Reduced premedication (10 mg)

(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication

Active Comparator group

Description:

Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.

Treatment:

Drug: Paclitaxel and carboplatin

Drug: Standard premedication (20 mg)

Other: Standard Treatment

(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel and carboplatin

Drug: Reduced premedication (5 mg)

Other: Proactive immune tolerance induction

(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication

Active Comparator group

Description:

Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.

Treatment:

Drug: Paclitaxel and carboplatin

Drug: Standard premedication (20 mg)

Other: Standard Treatment