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HRD and Resistance to PAPPi in EOC Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05310370
Enrollment
400
Registered
2022-04-04
Start date
2022-03-26
Completion date
2025-03-26
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Resistance, Epithelial Ovarian Cancer, Homologous Recombination Deficiency, Homologous Recombination Repair Gene Mutation, Overall Survival, Poly(ADP-ribose) Polymerase Inhibitor, Progression-free Survival

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.

Interventions

GENETICTesting of homologous recombination deficiency

A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Sponsors

Lei Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survivalOne yearProgression-free survival after the start of PARPi

Secondary

MeasureTime frameDescription
Overall survivalOne yearOverall survival after the start of PARPi
Severe adverse eventsOne yearSevere adverse events after the start of PARPi

Countries

China

Contacts

Primary ContactLei Li, M.D.
lileigh@163.com86-139-1198-8831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026