Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
- Conditions
- Ovarian CancerEndometrial CancerCervical Cancer
- Interventions
- Other: Proactive immune tolerance inductionOther: Standard Treatment
- Registration Number
- NCT06977594
- Lead Sponsor
- Seoul National University Hospital
- 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, after which all participants will continue the remaining cycles with standard treatment.
- Detailed Description
Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. While it follows the same stepwise dosing scheme as conventional desensitization therapy, it is uniquely implemented in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization before it occurs.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1028
- Patients receiving paclitaxel and carboplatin chemotherapy for the first time in their lifetime for gynecologic malignancies.
- Individuals who are able to read and voluntarily provide written informed consent.
- Aged 19 years or older.
- Individuals who do not wish to participate in this study voluntarily.
- Individuals who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proactive immune tolerance induction Proactive immune tolerance induction Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Proactive immune tolerance induction Paclitaxel and carboplatin Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Standard treatment (placebo) Standard Treatment Participants will receive standard treatment throughout all chemotherapy cycles. Standard treatment (placebo) Paclitaxel and carboplatin Participants will receive standard treatment throughout all chemotherapy cycles.
- Primary Outcome Measures
Name Time Method Hypersensitivity reaction incidence From chemotherapy initiation to 1 week after the last chemotherapy 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 Grade ≥2 events according to either CTCAE or Brown's Criteria.
- Secondary Outcome Measures
Name Time Method Chemotherapy completion rate From chemotherapy initiation to completion in each patient, an average of 1 year Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation.
Tumor Response Rate At chemotherapy completion in each patient, an average of 1 year This outcome measures the degree of tumor size reduction or disappearance in response to chemotherapy. The Objective Response Rate (ORR is defined 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.
Patients' quality of life From chemotherapy initiation to completion in each patient, an average of 1 year 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.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of