Randomized phase III trial of Lenvatinib versus Ramucirumab as a second-line treatment after immune check-point inhibitor for advanced hepatocellular carcinoma with alfa-fetoprotein >400 ng/mL - SELECT-400

eno Makoto0 个研究点目标入组 130 人开始时间: 2021年5月17日最近更新: 2023年10月17日

研究概览

暂无简介。

•1. Advanced hepatocellular carcinoma (HCC) confirmed by Radiological or histological assessment
•2. Not amenable to a liver directed therapy
•3. Intolerant or refractory to first-line systemic treatment containing immune check point inhibitor
•4. No prior therapy of EGFR-TKI or Ramucirumab
•5. ECOG performance status (PS) of 0-1
•6. Age >= 20 years old
•7. Adequate hematologic and renal function
•8. Child-Pugh class A
•9. AFP>=400ng/ml
•10. More than two weeks from the last treatment
•11. Expected prognosis of more than 12 weeks
•12. Provided written informed consent

•1. Moderate or severe pleural effusion
•2. Uncontrollable hypertension
•3. Urinary protein excretion of 2g/day or over
•4. With hepatic encephalopathy
•5. Synchronous or metachronous malignancies
•6. Active infection requiring systemic treatment
•7. Inability of oral food intake
•8. Brain or meningeal metastasis
•9. Pregnant and lactating females, and males and females unwilling to use contraception
•10. Severe psychosis
•11. Continuous use of systemic steroid or immune suppressant
•12. Interstitial pneumonia, fibroid lung, or severe emphysema
•13. Severe concomitant disease, such as cardiovascular, renal and gastrointestinal disorders, and uncontrolled diabetes mellitus)
•14. Unstable angina pectoris, or history of myocardial infarction within 6 months
•15. Hemorrhagic or thrombotic disease
•16. Blood transfusion or use of G-CSF within 2 weeks
•17. Other conditions not suitable for this study

发起方

eno Makoto