Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

Ovarian Cancer Clinical Trial

— HOPEI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05044091
• Other study ID #: JiangsuCIH010
• Status: Not yet recruiting
• Start date: September 15, 2021
• Est. completion date: September 2023

Study information

• Verified date: September 2021
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Jing Ni, MD
• Phone: +86 13327833586
• Email: nijingwulin[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• HRD
• Ovarian Cancer
• Ovarian Neoplasms
• PARP Inhibitor

Intervention

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

Locations

Country	Name	City	State
China	Xiaoxiang Chen, MD,PhD	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoxiang Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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