Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)：a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- chemotherapy response score(CRS) 3
研究概览
简要总结
Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All tissue samples harvested during IDS will be subjected to H&E expert pathological evaluation to confirm the diagnosis of high-grade serous ovarian cancer(HGSOC). Omental slides will be independently reviewed by two pathologists to determine those with the greatest amount of viable tumour, and one slide of each site will be selected. The two pathologists, who will be blinded to the written report and each other's results, will independently score each slide according to the CRS system.
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC
- •Patients with Fagotti score ≥8
- •Adequate kidney function (blood creatinine 58-96 µmol/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)
- •World Health Organization(WHO) score 0-2
排除标准
- •Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy.
- •Patients with complete intestine obstruction.
- •Expected life span ≤8 weeks.
- •Complicated with any other known malignancies.
- •Patients with poor cardiopulmonary function, which would limit compliance with study requirements.
结局指标
主要结局
chemotherapy response score(CRS) 3
时间窗: At the end of cycle 3 NACT (each cycle is 21 days)
the proportion of chemotherapy response score 3, which means a better outcome
次要结局
- progression-free survival(PFS)(From date of randomization until the date of first documented progression, assessed up to 3 years)
- overall survival(OS)(From date of randomization until the time of death from any cause, assessed up to 3 years)
- Rate of R0 resection(At the end of cycle 3 NACT (each cycle is 21 days),when IDS is conducted)
- NHIPEC-related adverse effects(during the procedure)