Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

Xiaoxiang Chen100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Ovarian Cancer HRD PARP Inhibitor

Interventions

PARP inhibitorDRUG

Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xiaoxiang Chen, MD,PhD

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, an average of 1 year

Central Contacts

Jing Ni, MD

CONTACT

+86 13327833586 nijingwulin@126.com

Xiaoxiang Chen, MD,PhD

CONTACT

Data from ClinicalTrials.gov

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