Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

NCT06977594 | Not Yet Recruiting DMC

• 1 other identifier: PINTO_C
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Keywords

Immune tolerance induction; Desensitization; Drug hypersensitivity; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Hypersensitivity reaction incidence

  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.

  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).

Secondary Outcomes (6)

• Chemotherapy completion rate

  From chemotherapy initiation to the last cycle in each patient, an average of 6 months

• 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).

• Patients' quality of life

  From chemotherapy initiation to the last cycle, an average of 6 months

• Tumor Response Rate

  At every third chemotherapy cycle in each patient

• Survival rate

  At study completion in each patient, an average of 1 year

Study Arms (6)

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

EXPERIMENTAL

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.

Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg)

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

ACTIVE COMPARATOR

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

Other: Standard Treatment; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg)

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

EXPERIMENTAL

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.

Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Reduced premedication (10 mg)

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

ACTIVE COMPARATOR

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

Other: Standard Treatment; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg)

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

EXPERIMENTAL

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.

Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Reduced premedication (5 mg)

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

ACTIVE COMPARATOR

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

Other: Standard Treatment; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg)

Interventions

Proactive immune tolerance induction OTHER

Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles

(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication; (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication; (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication

Standard Treatment OTHER

Standard treatment throughout all chemotherapy cycles

(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication; (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication; (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication

Paclitaxel and carboplatin DRUG

A chemotherapy regimen for gynecologic cancers.

(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication; (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication; (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication; (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication; (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication; (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication

Standard premedication (20 mg) DRUG

Premedication includes 20 mg of dexamethasone.

(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication; (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication; (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication; (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication

Reduced premedication (10 mg) DRUG

Premedication includes 20 mg of dexamethasone.

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

Reduced premedication (5 mg) DRUG

Premedication includes 5 mg of dexamethasone.

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

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Drug Hypersensitivity

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Hye-Ryun Kang, MD, PhD

CONTACT

+82-2-2072-0820; helenmed@snu.ac.kr

Jiyeon Park, MD

CONTACT

+82-2-2072-3291; creativepennant@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, placebo-controlled, parallel-group, open-label, clinical trial

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 18, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)