Adjuvant Hepatic Holmium-166-radioembolization in Patients With Unresectable Liver Metastases of Neuroendocrine Origin, Who Have Been Treated With Lutetium-177-dotatate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Response (RECIST 1.1 Partial plus complete)
研究概览
简要总结
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an interventional, treatment, non-randomized, open label, non-comparative, phase II study. 166Ho-RE will be performed via a catheter during angiography.
详细描述
Acronym :
Holmium Embolization Particles for Arterial Radiotherapy Plus 177Lu-dotatate in Salvage NET patients- HEPAR PLUS-trial.
Rationale:
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease.
Objective:
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
- •Patients must have given written informed consent.
- •Female or male aged 18 years and over.
- •Confirmed histological diagnosis NET, including bronchial carcinoids, and metastatic malignancy with liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
- •Patients must have been treated with 4 cycles of 200 mCi 177Lu-dotatate, the last cycle within 8-12 weeks of 166Ho-RE.
- •Life expectancy of 12 weeks or longer.
- •World Health Organisation (WHO) Performance status 0-
- •Liver disease with three or more measurable liver lesions according to the RECIST 1.1 criteria.
- •Negative pregnancy test for women of childbearing potential.
排除标准
- •Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.
- •Radiation therapy within the last 4 weeks before the start of study therapy.
- •The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
- •Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- •Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events grade 2 from previous anti-cancer therapy.
- •Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- •Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- •Leukocytes < 3.0 x 109/l and/or platelet count < 100 x 109/l.
- •Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •Pregnancy or nursing (women of child-bearing potential).
- •Patients suffering from diseases with an increased chance of liver toxicity.
- •Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- •Patients who are declared incompetent.
- •Previous enrolment in the present study or previous treatment with RE.
- •Female patients who are not using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR are less than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy.
- •Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
- •Patients with abnormalities of the bile ducts (such as stents) with an increased chance of infections of the bile ducts (papillotomy and cholecystectomy are allowed). Or evidence of extensive portal hypertension, splenomegaly, ascites or active hepatitis (B and/or C).
- •Body weight over 150 kg.
- •Severe allergy for i.v. contrast (Visipaque®), used for CT evaluation, pre-treatment angiography and treatment angiography.
- •Liver tumour involvement ≥70% as quantified on CT.
结局指标
主要结局
Response (RECIST 1.1 Partial plus complete)
时间窗: 3 months
To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study
次要结局
- AD Adverse events(1 year)
- Quality of Life (QoL)(3 months)
- Dosimetry(3 months)
- Biodistribution(3 months)