Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study Overview
Brief Summary
The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years or older
- •Pathological confirmation of epithelial ovarian cancer
- •With available tumor tissues
- •Given consents to participate the study
- •With detailed follow-up outcomes
Exclusion Criteria
- •Not meeting all of the inclusion criteria
- •Declining to accept PARPi as maintenance therapy after the major treatment for cancer
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: One year
Progression-free survival after the start of PARPi
Secondary Outcomes
- Overall survival(One year)
- Severe adverse events(One year)
Investigators
Lei Li
Professor
Peking Union Medical College Hospital