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NCT Number: NCT06977594

Proactive Immune Tolerance Induction in Chemotherapy for 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Cervical Cancer Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Hypersensitivity reaction incidence

    Time frame: 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

  1. Chemotherapy completion rate

    Time frame: 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.

  2. Severity of hypersensitivity reaction

    Time frame: 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).

  3. Patients' quality of life

    Time frame: 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.

  4. Tumor Response Rate

    Time frame: 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.

  5. Survival rate

    Time frame: 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.

  6. Recurrence Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hye-Ryun Kang, MD, PhD

CONTACT

[email protected]

+82-2-2072-0820

Jiyeon Park, MD

CONTACT

[email protected]

+82-2-2072-3291

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea Health Industry Development Institute
  • Seoul National University Boramae Hospital
  • Seoul National University Bundang Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 18, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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