Clinical Trial

SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer

Not Yet Recruiting Phase 3
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Summary
This study is a randomized, open-label, active-controlled, multicenter phase III clinical trial. It is planned to enroll 300 subjects with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with HER2 expression. The randomization will be stratified according to the following factors: 1) HER2 immunohistochemistry (IHC) expression status (HER2 IHC 1+ versus HER2 IHC 2+/3+); 2) whether the subject has previously received vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) inhibitors such as bevacizumab (yes versus no). Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (SHR - A1811) or the control treatment group (chemotherapy chosen by the investigator, namely liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine).
Trial Details
NCT Number NCT06990503
Lead Sponsor Tongji Hospital
Conditions Ovarian Cancer
Enrollment 300 participants
Start Date 2025-06-01
Primary Completion 2030-06-01 (estimated)
Study Completion 2035-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-25