Prospective evaluation of image and molecular fingerprint characterization to guide treatment with tyrosine kinase inhibitors in hepatocellular carcinoma - HCC fingerprint

niversitätsklinikum Tübingen0 个研究点目标入组 2 人开始时间: 2019年4月11日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.HCC patients with indication for the treatment with a tyrosine kinase inhibitor (TKI), irrespective of previous systemic therapies.
•2.If prior systemic therapies had been applied, progression has to be documented prior to the start of treatment with the TKI.
•3.Male or female = 18 years and written informed consent.
•4.Histologically confirmed advanced stage hepatocellular carcinoma, BCLC class B or C.
•5.Child-Pugh class A or B. Only patients with Child-Pugh index class B of not more than 7 will be included. Patients with untreatable ascites or hepatic encephalopathy > Grade 1 are excluded (see exclusion criteria).
•6.ECOG performance status 0, 1 or 2.
•7.Life expectancy of 12 weeks or more.
•8.At least one measurable lesion without previous local therapy and that is suitable for accurate repeated measurements as per mRECIST guidelines.
•9.Adequate hematological parameters, as demonstrated by:
•10.Hemoglobin = 9.0 g/dl (SI units: 5.6 mmol/l);
•11.WBC = 2.5 x 109/l;
•12.Platelets = 60 x 109/l;
•13.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 times upper limit of normal range (ULNR);
•14.Bilirubin = 3 mg/dl;
•15.Serum creatinine = 1.5 mg/dl (SI units: 132 µmol/l);
•16.Prothrombin Time (PT) International Normalized Ratio (INR) = 1.5.

•Patients who meet any of the following criteria are not eligible for study participation:
•1.Renal failure requiring hemo- or peritoneal dialysis.
•2.Patients with no adequate treatment for gastrointestinal bleeding and esophagus varices within 14 days prior to study entry.
•3.Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I.
•4.Altered mental status precluding understanding of the informed consent process.
•5. Pregnancy or breastfeeding mother.

发起方

niversitätsklinikum Tübingen