Clinical trial · Observational
The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HIPEC
- description
- HIPEC is given after primary debulking surgery or interval debulking.
- interventionNames
- Procedure: HIPEC
- label
- CONTROL
- description
- No HIPEC
Primary outcomes (1)
- measure
- PFS
- timeFrame
- from the date of recruitment to the time of recurrence, assessed up to 30 months
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- from the date of recruitment to the time of death from any cause, assessed up to 30 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available