NIPH Clinical Trials Search

JRCT ID: jRCT1031210167

Registered date:28/06/2021

Randomized phase III trial of Sorafenib versus Lenvatinib as a second-line treatment after immune check point inhibitor for advanced hepatocellular carcinoma

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHepatocellular carcinoma
Date of first enrollment27/09/2021
Target sample size164
Countries of recruitment
Study typeInterventional
Intervention(s)Eligible participants are randomaized to Sorafenib 800mg/day daily and Lenvatinib 8 or 12mg daily


Primary OutcomeOverall Survival
Secondary Outcomeprogression free survival, response rate, dsease controll rate, adverse event rate, siviere adverse event rate, Child-Pugh progression rate, Modified ALBI grade progression rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. 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. More than two weeks from the last treatment 10. Expected prognosis of more than 12 weeks 11. Provided written informed consent
Exclude criteria1. 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

Related Information


Public contact
Name Satoshi Kobayashi
Address 2-3-2, Nakao, Asahi, Yokohama, Knagawa Kanagawa Japan 241-8515
Telephone +81-45-520-2222
Affiliation Kanagawa Cancer Center
Scientific contact
Name Makoto Ueno
Address 2-3-2, Nakao, Asahi, Yokohama, Knagawa Kanagawa Japan 241-8515
Telephone +81-45-520-2222
Affiliation Kanagawa Cancer Center