SELECT-400

Phase 3

Recruiting

• Conditions: Hepatocellular carcinoma; Hepatocellular carcinoma, drug therapy

• Registration Number: JPRN-jRCT1031210092
• Lead Sponsor: eno Makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall servival

Secondary Outcome Measures

Name	Time	Method
progression free survival, response rate, dsease controll rate, adverse event rate, siviere adverse event rate, Child-Pugh progression rate, Modified ALBI grade progression rate