drugset / Trial / NCT06007586
Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients
Phase 3
Completed
143 enrolled
Sichuan Cancer Hospital and Research Institute
Medical High Level Talents Program · collabPeking Union Medical College Hospital Talent Cultivation Program · collabQilu Pharmaceutical Co., Ltd. · collabthe Norman Bethune's "Research Wing Promotion"-Supporting Research Projects · collab
RandomizedCrossoverTriple-blindPrevention
Summary
To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor. Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Optimal prophylaxis is uncertain. This trial evaluated whether adding the NK1 receptor antagonist aprepitant to standard two-drug prophylaxis (5-HT3 receptor antagonist plus dexamethasone) improves CINV control.
Timeline
- Start
- 2024-05-31
- Primary completion
- 2025-06-20
- Completion
- 2025-07-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 130 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 8 mg | Intravenous |
| Background | Ondansetron | Other / unclassified | 8 mg | Intravenous |