The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PFS
时间窗: from the date of recruitment to the time of recurrence, assessed up to 30 months
次要结局
- 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)