Ovarian Cancer, HRD, PARP Inhibitor
Conditions
Keywords
Ovarian caner, HRD, PARP inhibitor
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.
Interventions
DRUGPARP inhibitor
Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions
Sponsors
Xiaoxiang Chen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJing Ni, MD
Backup ContactXiaoxiang Chen, MD,PhD
Outcome results
None listed