NCT06142344招募中不适用
The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Feasibility
研究概览
简要总结
The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer.
Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >18 years
- •Patients with hormone positive and HER2 negative liver metastatic breast cancer
- •No extra-hepatic disease progression at evaluation of at least second line systemic chemotherapy
- •Suitable for TARE evaluated after the mapping angiography
- •Measurable target tumors in the liver according to RECIST 1.1
- •Liver tumor burden <50 %
- •ECOG performance score 0 to 1
- •Laboratory parameters: neutrophils >1000/μL; thrombocyte count >1000000 μL; eGFR >45/mL/min/1.73 m2; albumin > 3.0 g/dl, bilirubin < 1.5x ULN (unless Gilbert syndrome); aminotransferase (ALAT/ASAT) <3.0 ULN
- •Able to read Dutch
排除标准
- •Life expectancy ≤3 months
- •Patient eligible for other curative local liver therapy (ea. surgery, ablation)
- •Brain, pleural, peritoneal or extensive extra-hepatic visceral metastases
- •Other life-threatening disease (i.e. Dialysis, unresolved diarrhea, serious unresolved infections (HIV, HBV, HCV etc.))
- •Contraindication for angiography or MRI
- •Significant toxicities due to prior cancer therapy that have not resolved before the initiation of the study, if the investigator determines that the continuing complication will compromise the safe treatment of the patient
- •Prior or planned embolic intra-arterial liver directed therapy (TACE, TAE, TARE)
- •Prior or planned external or internal radiation therapy of the liver
- •Cirrhosis or portal hypertension
- •Main portal vein thrombosis
- •Intervention for, or compromise of, the Ampulla of Vater
- •Ascites (except minor focal ascites)
- •Baseline use of analgesics for abdominal pain
- •Pregnancy (Women at childbearing potential need at least one form of birth control) and breastfeeding
- •Flow to extra hepatic vessels not correctable by reposition or embolization
- •Estimated dose to the lungs greater than 30 Gy in a single administration or 50 Gy cumulatively
- •Target tumoral absorbed dose of < 90Gy or an absorbed dose to the normal liver parenchyma of >50Gy (in case of whole liver treatment)
结局指标
主要结局
Feasibility
时间窗: Up to 3 months after intervention
The percentage of patients were radioembolization and systemic chemotherapy is safely feasible. Safety is defined as percentage of 90 day post-radioembolization (CTCAE/SIR grade 3 or higher) which lead discontinuation of the current systemic chemotherapy. Time to re-start chemotherapy after intervention in days will be collected.
次要结局
- Lesion- and patient-based response(Up to 3 months after intervention)
- Quality of Life during study(From start inclusion to 3 months after intervention)
- Overall toxicity associated with study intervention(Up to 3 months after intervention)
研究者
研究点 (4)
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