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NCT05310370 Clinical Trial

HRD and Resistance to PAPPi in EOC Patients

Epithelial Ovarian Cancer Clinical Trial

Official title:
Correlation Between Homologous Recombination Deficiency Status and Resistance to PARP Inhibitors in Chinese Epithelial Ovarian Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05310370
Other study ID # EOC-HRD3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 26, 2022
Est. completion date March 26, 2025

Study information
Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date March 26, 2025
Est. primary completion date March 26, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years or older - Pathological confirmation of epithelial ovarian cancer - With available tumor tissues - Given consents to participate the study - With detailed follow-up outcomes Exclusion Criteria: - Not meeting all of the inclusion criteria - Declining to accept PARPi as maintenance therapy after the major treatment for cancer

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Testing of homologous recombination deficiency
A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival Progression-free survival after the start of PARPi One year
Secondary Overall survival Overall survival after the start of PARPi One year
Secondary Severe adverse events Severe adverse events after the start of PARPi One year
See also
  Status Clinical Trial Phase
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Completed NCT04546373 - Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Completed NCT01442051 - Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer N/A
Not yet recruiting NCT04983550 - Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC Phase 2
Completed NCT02480374 - Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer Phase 1
Recruiting NCT01680575 - Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer N/A
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Not yet recruiting NCT04889495 - A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
Not yet recruiting NCT06010667 - A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer
Recruiting NCT06085456 - Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study
Completed NCT06366997 - Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test
Active, not recruiting NCT05212779 - Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease
Recruiting NCT04620954 - Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin Phase 1/Phase 2
Completed NCT02312661 - Study of Metformin With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer Phase 1
Completed NCT01666444 - VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Phase 2
Completed NCT01891344 - A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) Phase 2