Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer Patients With PARP Inhibitors Resistance: a Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
At present, the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging, and there is no research on the application of hyperthermic intraperitoneal chemotherapy(HIPEC) for the above-mentioned patients. Therefore, this study aims to explore the safety and efficacy of secondary cytoreduction combined with hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer after maintenance therapy with PARP inhibitors through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the treatment options for ovarian cancer patients in the era of PARP inhibitors, thereby improving the overall treatment level and prognosis of ovarian cancer.
详细描述
- Overall design This is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for recurrent ovarian cancer after maintenance therapy with PARP inhibitors.
- Sample size calculation This clinical trial aims to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for the maintenance treatment of recurrent ovarian cancer with PARP inhibitors. The median progression-free survival of patients who received maintenance therapy with PARP inhibitors in our center is 11 months. It is expected that HIPEC can reduce the risk of recurrence by 30%. After 1 year of enrollment and 2 years of follow-up, the alpha value is 0.05. Considering the participants who withdrew from the study midway or dropped out due to loss to follow-up, this study intends to include 94 participants.
- Methods Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument, after the surgical operation is completed, four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively. Connect all pipelines and preheat the instrument before starting treatment. The treatment temperature is controlled at 43 ℃± 0.1 ℃, the treatment time is 90 minutes, and the circulation pump flow rate is 400-600ml/min. Within 48 hours after the surgery, cisplatin 75mg/㎡ was added to 3000ml of physiological saline for intraperitoneal hot infusion.
- Data statistics Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with previously diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- •Maintain treatment with PARP inhibitors before recurrence;
- •The imaging assessment is suitable, and the patient agrees to undergo further cytoreductive surgery;
- •The outcome of recurrent surgery is R0 or R1 resection;
- •Sign the informed consent form;
- •Age≥18 years old;
排除标准
- •Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- •Inappropriate imaging evaluation or physical intolerance for surgical patients;
- •Isolated lymph node recurrence
- •Patients who undergo unsatisfactory tumor reduction surgery (R2 resection) due to recurrence;
- •Patients who are unwilling to participate in the clinical trial.
研究组 & 干预措施
Recurrent Ovarian Cancer After PARPi Therapy
After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery.
干预措施: Secondary cytoreduction (Procedure)
Recurrent Ovarian Cancer After PARPi Therapy
After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery.
干预措施: Hyperthermic intraperitoneal chemotherapy (Drug)
结局指标
主要结局
PFS
时间窗: Two years
Progression free survival
次要结局
- OS(Two years)
研究者
Xiaohua Wu MD [zzhong]
Director of Gynecological Oncology
Fudan University