The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical benefit rate (CBR)
研究概览
简要总结
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of old;
- •WHO performance of status 0-1;
- •Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma;
- •Treatment naïve patients as first-line treatment;
- •Progression on or intolerance to first-line systemic chemotherapy as second-line treatment;
- •No symptoms of gastrointestinal obstruction;
- •No contraindications for the planned systemic therapy or laparoscopy;
- •No previous PIPAC/IP/HIPEC;
- •No other concurrent malignancies or any other malignancy within 6 months prior to enrolment;
- •Able to give written informed consent.
排除标准
- •A history of allergic reaction to platinum containing compounds or doxorubicin;
- •Pregnant or breastfeeding;
- •Any extra-peritoneal metastases;
- •Renal impairment, defined as GFR less than 40 mL/min;
- •Impaired liver function defined as bilirubin over 1.5 × UNL;
- •Inadequate haematological function
- •Leucocyte < 3.00 × 109/L
- •Absolute neutrophil counts < 1.50 × 109/L
- •Platelet < 100 × 109/L
研究组 & 干预措施
PIPAC
干预措施: Pressured Intraperitoneal Aerosol Chemotherapy (Drug)
结局指标
主要结局
Clinical benefit rate (CBR)
时间窗: At the end of Cycle 3 (each cycle is 6 to 8 weeks)
Clinical benefit rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST).
次要结局
未报告次要终点
研究者
Dr. WONG, Yu Hong Ian
Clinical Assistant Professor
The University of Hong Kong