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

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: HIPEC

• Registration Number: NCT05265117
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-03
• Study Start: 2022-04-01
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

• Age 18-70 years
• Eastern Cooperative Oncology Group (ECOG) score 0-1
• Adequate kidney function (blood creatinine 58-96µmol/L)
• Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L)
• Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5
• surgery with residual
• eligible to the maintenance therapy of olaparib plus bevacizumab

Exclusion Criteria

• Expected life span ≤8 weeks
• Complicated with any other known malignancies
• Patients with dysfunction of swallow and digestion
• Patients who had received any kind of poly adenosinediphosphate-ribose polymerase（PARP）inhibitor
• refractory hypertension

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIPEC	HIPEC	HIPEC is given after primary debulking surgery or interval debulking.

Primary Outcome Measures

Name	Time	Method
PFS	from the date of recruitment to the time of recurrence, assessed up to 30 months

Secondary Outcome Measures

Name	Time	Method
overall survival	from the date of recruitment to the time of death from any cause, assessed up to 30 months
adverse effect	from the date of recruitment up to 30 months

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China