NCT04826432终止2 期
Efficacy and Feasibility of Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis - a Phase II Randomized Multicentric Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- postoperative digestive leakage
研究概览
简要总结
To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 years and 75 years included
- •ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2
- •Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies
- •Curative intent resection obtained by a complete resection according to the Completeness of Cytoreduction score (CC) (CC 0-1) followed by HIPEC Different intraperitoneal drug administration modalities such as neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy (NIPS) or pressurized intra-peritoneal aerosol chemotherapy (PIPAC) does not represent exclusion criteria.
- •Absence of extra-peritoneal metastatic disease or limited hepatic or lung metastases easily amenable to curative-intent resection or ablation
- •Intraoperative Peritoneal Cancer Index (PCI score) ≥ 10
- •Visceral resection with at least one digestive anastomosis with or without loop ileostomy or pancreatic or biliary resection.
- •Negative serum pregnancy test for women of childbearing potential within 7 days prior to therapy
- •Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Sexually active males patients must agree to use condom or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception during the same period.
- •Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- •Patients must be affiliated to a social security system or beneficiary of the same
排除标准
- •Macroscopically incomplete surgical resection (CC 2)
- •Standard contraindications to pasireotide:
- •patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl (14 mMol/L)
- •patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia including a corrected QT (QTc) interval longer than 450 msec, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
- •patients with liver disease such as severe hepatic impairment (Child Pugh C), chronic active hepatitis or chronic persistent hepatitis with abnormal coagulation (INR>1.5).
- •patients with the presence of active or suspected acute or chronic uncontrolled infection
- •hypersensitivity to somatostatin analogues or any component of pasireotide formulations
- •patients with uncontrolled hypothyroidism
- •Patients participating or who have participated to another study evaluating the effect of a new drug other than pasireotide within 1 month prior to dosing
- •Patient who have already participated to this study (a patient can only be included once in the study)
- •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
- •Women who are pregnant or likely to be so, or who are breastfeeding
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
研究组 & 干预措施
Pasireotide
Experimental
0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours
干预措施: Pasireotide 0.9 MG/ML (Drug)
Placebo
Placebo Comparator
0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours
干预措施: Saline water (Other)
结局指标
主要结局
postoperative digestive leakage
时间窗: 97 days
The rate of clinically relevant (NCI CTCAE v5 ≥ grade 3) postoperative digestive leakage at 97 days
次要结局
未报告次要终点
研究者
研究点 (1)
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