SELECT-400

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031210092

Enrollment

130

Registered

2021-05-17

Start date

2021-05-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma Hepatocellular carcinoma, drug therapy

Interventions

Eligible participants are randomized to Lenvatinib 8 or 12mg orally, once daily and Ramucirumab 8 mg/kg div, bi-weekly

Lenvatinib, Ramucirumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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. 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
overall servival	—

Secondary

Measure	Time frame
progression free survival, response rate, dsease controll rate, adverse event rate, siviere adverse event rate, Child-Pugh progression rate, Modified ALBI grade progression rate	—

Contacts

Public ContactSatoshi Kobayashi

Kanagawa Cancer Center

kobayashis@kcch.jp+81-45-520-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026