A multicenter open-label randomized controlled prospective phase II study evaluating the efficacy of Selective Internal Radiation Therapy (Yttrium-90 glass microspheres) combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 8
- 主要终点
- Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm
研究概览
简要总结
To assess efficacy of the combination of neoadjuvant SIRT and capecitabine in neoadjuvant setting of patients with resectable cholangiocarcinoma
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years-old
- •ECOG Performance Status <2
- •Histologically-proven ICC
- •No previous treatment for ICC
- •Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board
- •Significant risk of close margins, defined as: Resection margin predicted by the surgeon <1cm or Tumour > 5cm or Multifocal lesion deemed resectable, validated by a Surgical Review Board
- •Registration with a social security scheme
- •Patient information and signature of informed consent or legal representative
排除标准
- •Severe fibrosis (F3) ou cirrhosis (F4)
- •Other invasive malignancies
- •Patient participate to an interventional study that tests another medical intervention before surgery
- •Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant
- •Minors, individual deprived of liberty, or under any kind of guardianship
- •Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons
- •Inadequate haematological, hepatic, renal and coagulation functions: Haemoglobin ≤ 8,5 g/dl, Neutrophils < 1,5 Giga/L, Platelets < 60 Giga/L, Bilirubin > 34 µmol/L, ASAT/ALAT > 5 x ULN, Creatinine clearance < 30 ml/min (MDRD), TP et INR > 2,3 ULN, TCA > 1,5 x ULN
- •Uracil blood level >16 ng/mL
- •Respiratory insufficiency
- •Significant heart disease or history of heart rhythm disorders, myocardial infarction or angina pectoris in the 6 months prior to inclusion
- •Presence of microvacuolar steatosis > 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned
- •Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis)
- •Previous chemotherapy (including for another cancer)
- •Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer)
结局指标
主要结局
Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm
Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm
Frequency of subjects actually resected
Frequency of subjects actually resected
Frequency of subjects with R0 and R1 resection
Frequency of subjects with R0 and R1 resection
Frequency of subjects with an observed objective response
Frequency of subjects with an observed objective response
Mean percentage of tissue with necrosis in resected specimen
Mean percentage of tissue with necrosis in resected specimen
Disease-Free survival
Disease-Free survival
Overall survival
Overall survival
次要结局
未报告次要终点
研究者
Julien EDELINE
Scientific
Centre De Lutte Contre Le Cancer Eugene Marquis