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Clinical Trials/NCT05310370
NCT05310370
Recruiting
Not Applicable

Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients

Lei Li1 site in 1 country400 target enrollmentMarch 26, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epithelial Ovarian Cancer
Sponsor
Lei Li
Enrollment
400
Locations
1
Primary Endpoint
Progression-free survival
Status
Recruiting
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2022
End Date
March 26, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

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)

Study Sites (1)

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