NCT05265117

The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 310 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

Ovarian cancer is associated with the highest mortality of all gynecologic cancers. In patients with newly diagnosed advanced ovarian cancer after platinum-containing chemotherapy plus bevacizumab therapy, maintenance therapy with olaparib plus bevacizumab significantly prolongs progression-free survival (PFS) in the intended population and is recommended by guidelines. However, study shows those homologous recombinant repair defect (HRD) but Breast Cancer Susceptibility Gene(BRCA) wild type have limited benefit from maintenance therapy with olaparib plus bevacizumab when surgery is with residual(no-R0). Can hyperthermic intraperitoneal chemotherapy(HIPEC) improve the benefits of first-line maintenance therapy in patients with non-R0 resection, HRD? The cohort study will enroll 310 patients with HRD and no-R0 resection who conduct HIPEC during primary treatment and then have olaparib plus bevacizumab as maintenance. Follow-up period is 30 months. The primary endpoint is PFS.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	HIPEC	HIPEC is given after primary or interval debulking surgery.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2022-03-03
• Last updated: 2023-02-17

Locations

1 site across 1 country: China