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An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 300 |
| Start date | 2025-03-13 |
| Completion | 2027-12 |
Conditions
- Ovarian Cancer
Interventions
- SHR-A1811
- Paclitaxel Injection
- Doxorubicin Hydrochloride Liposome Injection
- Gemcitabine Hydrochloride for Injection
- Topotecan Hydrochloride for Injection
Primary outcomes
- Progression free survival (PFS) — From day 1 to 10 months.
Countries
China