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Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

NCT05044091 — Unknown, 100 participants, Xiaoxiang Chen

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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

RegistryNCT05044091, acronym HOPEI
StatusUnknown
Study typeObservational
Enrollment100 (Estimated)
SponsorXiaoxiang Chen (Other)
ConditionsOvarian Cancer, HRD, PARP Inhibitor
InterventionsPARP inhibitor (Drug)
Datesstart 2021-09-15 (estimated), primary completion 2022-09-01 (estimated), completion 2023-09-01 (estimated), first posted 2021-09-14, last updated 2021-09-14
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ovarian/fallopian tube/primary peritoneal cancer patientsDrug: PARP inhibitorovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks
  • PARP inhibitor (Drug), also known as Lynparza, Zejula: Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: Female, ages: 18 Years to any

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)

FacilityCityCountryStatus
Xiaoxiang Chen, MD,PhDNanjing, JiangsuChina

+Investigators

My Notes