Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of patients with major toxicities of at least CTCAE Grade 3 and above
研究概览
简要总结
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Unesectable PM Group:
- •Age ≥ 21 years old
- •ECOG < 3
- •Fit for systemic chemotherapy treatment
- •Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L
- •Adequate renal function (e-GFR > 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)
- •Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3 upper limit of normal)
- •No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin
- •No contraindications to general anaesthesia and diagnostic laproscopy procedure
- •Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin)
- •Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries
- •Peritoneal-dominant metastatic disease
- •For the Extensive PM Group:
- •All the above mentioned criteria as for the unresectable group, with the addition of the following:
- •Not suitable for curative cytoreductive surgery (CRS) & hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6 in UGI ECOG < 3
- •In UGI PM patients, progression while on bidirectional chemotherapy
排除标准
- •Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases
- •Any medical or psychiatric condition(s) which would preclude informed consent
- •Patient is pregnant or nursing
- •GI PM patients with PCI >6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
研究组 & 干预措施
Unresectable PM group
Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.
干预措施: PIPAC (Combination Product)
Extensive PM group
Patients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases.
干预措施: PIPAC (Combination Product)
结局指标
主要结局
Number of patients with major toxicities of at least CTCAE Grade 3 and above
时间窗: Up to 4 weeks after each PIPAC procedure
To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Number of patients with minor toxicities of CTCAE Grade 1 and 2
时间窗: Up to 4 weeks after each PIPAC procedure
Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Length of hospitalisation stay for each PIPAC procedure
时间窗: Through study completion, an average of half a year
次要结局
- Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire(At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure))
- Ascites volume(During each PIPAC procedure)
- Percentage of patients that convert to curative surgery(From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks)
- Intra-operative Peritoneal Carcinomatosis Index (PCI) score(During each PIPAC procedure)
- Peritoneal Regression Grading Score (PRGS) from PM biopsy(At each PIPAC procedure)
- Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire(At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure))
- Progression free survival(From the start of the first PIPAC procedure, up to 5 years)
- Overall survival(From the start of the first PIPAC procedure, up to 5 years)