Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel and carboplatin | Drug | — | UNRESOLVED |
| Proactive immune tolerance induction | Other | — | UNRESOLVED |
| Reduced premedication (10 mg) | Drug | — | UNRESOLVED |
| Reduced premedication (5 mg) | Drug | — | UNRESOLVED |
| Standard premedication (20 mg) | Drug | — | UNRESOLVED |
| Standard Treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication
- 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.
- interventionNames
- Other: Proactive immune tolerance induction
- Drug: Paclitaxel and carboplatin
- Drug: Standard premedication (20 mg)
- type
- ACTIVE_COMPARATOR
- label
- (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication
- description
- Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
- interventionNames
- Other: Standard Treatment
- Drug: Paclitaxel and carboplatin
- Drug: Standard premedication (20 mg)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available