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

JRCT ID: jRCT1031210167

Registered date:28/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 27/09/2021
• Target sample size: 164
• Study type: Interventional
• Intervention(s): Eligible participants are randomaized to Sorafenib 800mg/day daily and Lenvatinib 8 or 12mg daily

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: progression 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 maximum: Not applicable
• Gender: Both

Include criteria

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. More than two weeks from the last treatment
10. Expected prognosis of more than 12 weeks
11. Provided written informed consent

Exclude criteria

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

Related Information

• Primary Sponsor: Ueno Makoto
• Secondary Sponsor: Furuse Junji