Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Status:
Recruiting
Trial end date:
2023-07-30
Target enrollment:
Participant gender:
Summary
Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous
ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal
instability, somatic copy number variation profiles and somatic mutations. The clinical
treatment of ESC also refers to the treatment model of HGSOC. The PARP inhibitor niraparib
used in this study, which was approved by FDA for the maintenance treatment of adult patients
with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in
complete or partial response to platinum-based chemotherapy on March 27, 2017.
The homologous recombination related gene mutations in total endometrial cancer accounted for
22%. Homologous Recombination Repair Defect (HRD) +ARID1A accounted for 48%, and 53% of
endometrial cancer cell lines were sensitive to PARP inhibitors. The incidence of HRD in
endometrial cancer with high copy number (the pathological type is mainly ESC) is 50%,
suggesting potential clinical applications of PARP inhibitors for the treatment of ESC.
Phase:
Phase 2
Details
Lead Sponsor:
Shandong University
Collaborators:
Sun Yat-sen University Tongji Hospital Women's Hospital School Of Medicine Zhejiang University Zai Lab (Shanghai) Co., Ltd.