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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: HIPEC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIPEC<br>HIPEC is given after primary debulking surgery or interval debulking. | Procedure: HIPEC<br>* HIPEC is given after primary or interval debulking surgery.<br>|
| CONTROL<br>No HIPEC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | from the date of recruitment to the time of recurrence, assessed up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |