Intraperitoneal Irinotecan Combined With Systemic Therapy for Patients With Gastric Peritoneal Metastases: A Phase II, Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Feasibility of intraperitoneal administration of irinotecan
研究概览
简要总结
This is a phase II study conducted in three hospitals in the Netherlands (Erasmus MC in Rotterdam, Catharina Hospital in Eindhoven, and the Netherlands Cancer Institute in Amsterdam). A total of 55 patients will take part. The aim is to test whether a new combination treatment is feasible for patients with gastric peritoneal metastases (PM). The treatment includes chemotherapy (intraperitoneal irinotecan and standard systemic therapy such as CAPOX or FOLFOX), and may also include nivolumab or trastuzumab, depending on biomarker results.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma
- •Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score ≥ 1)
- •WHO-performance score of 0 to 1 with a life expectancy greater than or equal to three months
- •Aged 18 years or older
- •Written informed consent according to the ICH-GCP and national/local regulations
排除标准
- •Distant metastases other than peritoneal metastases or metastatic lymph nodes
- •Prior palliative systemic therapy for gastric cancer
- •Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study
- •Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis
- •Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
- •Any contra-indication for the (planned) systemic chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, persistent neurologic toxicity after (neo-)adjuvant oxaliplatin based systemic therapy), as determined by the treating medical oncologist
- •Inadequate organ functions (defined as a hemoglobin <5.0 mmol/l, an absolute neutrophil count <1.5 x 109/l, platelet count <100 x 109/l, creatinine clearance <30 ml/min, bilirubin >2x ULN and liver transaminases >2.5x ULN)
- •Pregnant or lactating women
- •Concomitant participation in any clinical study that could modify the outcomes relevant to this study
- •Absence of assurance of compliance with the protocol
研究组 & 干预措施
Intraperitoneal chemotherapy arm
Patients in this group will receive intraperitoneal irinotecan in addition to standard systemic therapy
干预措施: intraperitoneal chemotherapy (Drug)
结局指标
主要结局
Feasibility of intraperitoneal administration of irinotecan
时间窗: From enrollment until the completion of all chemotherapy cycles: either 6 cycles of CAPOX (21 days per cycle) or 8 cycles of FOLFOX (14 days per cycle)
Percentage of patients who completed all planned cycles of intraperitoneal irinotecan in combination with systemic therapy (6 cycles in the case of CAPOX, 8 cycles in the case of FOLFOX)
次要结局
未报告次要终点
研究者
Pieter Christiaan van der Sluis
Dr.
Erasmus Medical Center