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 - S7-PRODIGE-SIROCHO

Centre Régional de lutte contre le Cancer Eugène Marquis0 个研究点目标入组 62 人开始时间: 2021年9月2日最近更新: 2022年1月24日

试验速览

暂无简介。

•Age > 18 years-old,
•ECOG Performance Status <2
•Histologically-proven ICC
•No previous treatment,
•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
•-Tumour > 5cm
•-Multifocal lesion deemed resectable, validated by a Surgical Review Board
•Patient information and signature of informed consent or legal representative.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•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,
•Comorbidity precluding surgical resection, such as severe heart disease
•Other invasive malignancies in the past 3 years,
•Patient participate to an interventional study that tests another medical intervention before surgery.

发起方

Centre Régional de lutte contre le Cancer Eugène Marquis