NCT01912053已完成2 期
An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Radiological response rate to the treatment with the association of chemotherapy and radioembolization
研究概览
简要总结
The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed intra-hepatic cholangiocarcinoma.
- •Measurable target of at least 2 cm diameter.
- •Healthy liver or cirrhosis CHILD < B
- •Age ≥ 18 years.
- •Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes < 3 cm, less than 5 lung nodes < 11 mm).
- •Creatinine clearance (calculated with Cockcroft and Gault formula) ≥ 55 ml/min, polymorphonuclear neutrophils ≥ 1500 G/L, platelets ≥ 80 G/L, prothrombin ≥ 40% (INR ≤ 2.3), serum albumin ≥ 28 g/l, serum bilirubin ≤ 3 x LSN.
- •Pregnancy test: negative for women of childbearing potential.
- •Reliable contraception for a childbearing couple, men and woman must have an reliable contraception during the treatment and until 6 months following the end of the treatment by chemotherapy
- •Signed informed consent form.
- •Patient with national health insurance.
排除标准
- •Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.
- •Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).
- •Primary sclerosing cholangitis.
- •History of chemoembolization or radioembolization.
- •Cirrhose CHILD > B7
- •Portal vein trunk tumoral thrombosis
- •History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.
- •Contra indication of Gemcitabine and/or Cisplatin.
- •Other invasive active cancer, excepting in situ cervical cancer and basocellular or spino cellular skin cancer treated adequately. Any history of cancer not considered as completely cured for at least one year.
- •Technical failure of the diagnostic arteriography.
- •Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.
- •Dosimetry study predicting lung exposure > 30 Gy.
- •Any unstable medical history (diabetes, hypertension ...).
- •History of organ transplant.
- •Symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris.
- •An evolutive neuropathy.
- •Patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before.
- •Pregnant patient or patient with breastfeeding.
- •Patient under administrative supervision.
- •Regular follow-up impossible for various reasons (psychological, familial, economical, and social).
研究组 & 干预措施
Therasphere®
Experimental
Therasphere® in association with Gemcitabine and Cisplatin
干预措施: Therasphere® in association with Gemcitabine and Cisplatin (Radiation)
结局指标
主要结局
Radiological response rate to the treatment with the association of chemotherapy and radioembolization
时间窗: 3 months after radioembolization
Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks
次要结局
- Change in metabolic activity measured by TEP(Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres)
- Changes of liver volume(Up to 24 months)
- Tumoral and non-tumoral dosimetric assessment of the liver(Up to 6 months)
- Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4.(Up to 24 months)
- Tumor markers changes (CA19.9, CEA and AFP)(Up to 24 months)
- Radiological response rate by the CHOI criteria(Up to 24 months)
研究者
研究点 (7)
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