Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

Study Overview
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Brief Summary
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Homologous recombination deficiency (HRD) is an important molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.

Detailed Description
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This study intends to perform HRD testing of ovarian cancer in real world from China and correlate HRD status and clinical characteristics with therapeutic outcomes.

Official Title
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Homologous Recombination Deficiency Associated With Response to Poly (ADP-ribose) Polymerase Inhibitors in Ovarian Cancer Patients: the First Real-word Evidence From China

Conditions
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HRD, PARP Inhibitor, Ovarian Cancer

Intervention / Treatment
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* Drug: PARP inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects join the study voluntarily and sign informed consent; Female subjects are older than 18 years; ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2; Life expectancy≥3 months; Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology; Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks. Exclusion Criteria: Personnel involved in the formulation or implementation of the research plan; Patient participated in other clinical trails using other experimental drugs at the same time as the study; The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ; Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ovarian/fallopian tube/primary peritoneal cancer patients<br>ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks | Drug: PARP inhibitor<br>* Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions<br>* Other names: Lynparza, Zejula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1. | Through study completion, an average of 1 year | 
| Progression Free Survival (PFS) | PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian caner, HRD, PARP inhibitor