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

Sun Yat-sen University

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Procedure: HIPEC

Study type: Observational

Funder types: Other

Identifiers

NCT05265117

2021-KY-073

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

310 participants in 2 patient groups

HIPEC

Description:

HIPEC is given after primary debulking surgery or interval debulking.

Treatment:

Procedure: HIPEC

CONTROL

Description:

No HIPEC