2023-509463-24-01进行中（未招募）2 期
A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
Amsterdam UMC5 个研究点 分布在 4 个国家目标入组 146 人开始时间: 2024年12月12日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 146
- 试验地点
- 5
- 主要终点
- Progression free survival
研究概览
简要总结
To determine the progression free survival (PFS) benefit of nal-IRI combined with S-1, compared with nal-IRI combined with 5-FU/LV, in subjects pre-treated with gemcitabine based chemotherapy for metastatic pancreatic ductal adenocarcinoma, or progression within 6 months of adjuvant gemcitabine treatment.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide written informed consent
- •≥ 18 years of age
- •Histologically or cytologically confirmed adenocarcinoma of pancreas
- •Documented metastatic disease, according to RECIST 1.
- •Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment
- •Adequate hepatic (serum bilirubin total between 0-17 μmol/L, AST between 0-40 U/L, ALT between 0-34 U/L, renal (creatinine between 65-95 μmol/L) and hematological (hemoglobin between 7.5-10 mmol/L, platelets between 150-400 10E9/L, leukocytes between 4.0-10.5 10E9/L) function
排除标准
- •Serum total bilirubin ≥1.5 x ULN (biliary drainage is allowed for biliary obstruction)
- •Current use or any use in last two weeks of strong CYP2A6- enzyme inhibitors, CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
- •Known hypersensitivity to any of the components of liposomal irinotecan (Nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
- •Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
- •Previous treatment with fluoropyrimidine therapy
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (Nal-IRI).
- •or male patients: unwilling to use contraception during treatment and 4 months following last dose of Nal-IRI and 6 months after S-1
- •Contraception required for 6 months following the last dose of S-1
- •Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.
- •Severe renal impairment (CLcr ≤ 30 ml/min)
- •Inadequate bone marrow reserves as evidenced by: a. ANC ≤ 1,5 x 10 9 /L; or b. Platelet count ≤ 100 x 10 9 /L;
- •WHO/PS 2 or higher
- •Any clinically significant disorder impacting the risk-benefit balance negatively per physician’s judgment
- •Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
- •Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
- •NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings
- •Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician’s opinion might compromise the patient’s health
结局指标
主要结局
Progression free survival
Progression free survival
次要结局
- Overall survival
- Response rate according to RECIST 1.1
- Adverse events according to NCI CTC version 4.0
- Quality of life (QLQ-C30)
研究者
J.W. Wilmink
Scientific
Amsterdam UMC
研究点 (5)
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