Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

• Conditions: HRD; PARP Inhibitor; Ovarian Cancer
• Interventions: Drug: PARP inhibitor

• Registration Number: NCT05044091
• Lead Sponsor: Xiaoxiang Chen

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-04
• Last Update Submitted: 2021-09-04
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14
• Study Start: 2021-09-15
• Primary Completion: 2022-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Subjects join the study voluntarily and sign informed consent;
2. Female subjects are older than 18 years;
3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
4. Life expectancy≥3 months;
5. 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;
6. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion Criteria

1. Personnel involved in the formulation or implementation of the research plan;
2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
3. 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;
4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ovarian/fallopian tube/primary peritoneal cancer patients	PARP inhibitor	ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Through study completion, an average of 1 year	ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
Progression Free Survival (PFS)	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Xiaoxiang Chen, MD,PhD; 🇨🇳 Nanjing, Jiangsu, China