The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study
NCT ID: NCT05265117
Last Updated: 2023-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
310 participants
OBSERVATIONAL
2022-04-01
2025-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIPEC
HIPEC is given after primary debulking surgery or interval debulking.
HIPEC
HIPEC is given after primary or interval debulking surgery.
CONTROL
No HIPEC
No interventions assigned to this group
Interventions
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HIPEC
HIPEC is given after primary or interval debulking surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Locations
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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2021-KY-073
Identifier Type: -
Identifier Source: org_study_id
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