NCT06478719 To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
| NCT ID | NCT06478719 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Febico Biomedical Corp. |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2027-06-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2024-06-24 with a primary completion date of 2027-06-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to assess the efficacy of FB-1603 on improving liver function impairment in hepatocellular carcinoma patients receiving transarterial chemoembolization. The main question it aims to answer is: Changes in the level of liver function parameters, including AST, ALT, or total bilirubin, from baseline to Visit 3, Visit 4, Visit 5, and Visit 6 There is a comparison group: Researchers will compare arm 1 placebo to see if FB-1603 is work to treat the liver function. Participants will 1. Take drug FB-1603 990mg/day, FB-1603 1980mg/day or a placebo every day for 10 weeks. 2. Visit the clinic on day 4, 7, 10, 14, 28, 56 and 84 (follow-up)
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-75 years (inclusive) of either gender 2. Willing and able to provide signed informed consent 3. Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology 4. Subject has the willingness to undergo TACE 5. ECOG performance Status of 0-1 6. The patient is expected to survive more than 3 months 7. Laboratory values should meet all the following standards at the screening visit: A. AST, ALP and ALT are ≤ 5x ULN. B. International Normalized Ratio (INR) ≤ 1.5 C. Prothrombin time \< 4 sec above upper limit of normal D. Absolute neutrophil count ≥ 1.5×10\^9/L; Hemoglobin ≥ 9 g/dL; platelet ≥ 50×10\^9/L. E. Total bilirubin \< 2.5 mg/dL F. Serum creatinine \< 2 mg/dL 8. With liver stiffness measurement \>7 kPa (assessed by FibroScan®) or \> 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI)) Exclusion Criteria: 1. Patients with evidence of macrovascular invasion 2. Patients with evidence of extrahepatic spread 3. Any condition representing a contraindication to TACE as determined by the investigators 4. Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, and ascites 5. Patients with acute or chronic active hepatitis B or C infection and are recommended to receive HBV or HCV treatment, e.g., Patient with HBV DNA ≥ 20,000 IU/ml or with detectable HCV RNA 6. Patients who have severe organic diseases on heart, lungs, brain, kidney, and gastrointestinal tract by the judgment of investigators 7. Patients with chronic pancreatitis 8. Patients who are taking any prohibited drugs that might interfere the trial 9. Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis 10. Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit
Contact & Investigator
Kai-Wen Huang, MD, MS, PhD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT06478719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06478719 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06478719 currently recruiting?
Yes, NCT06478719 is actively recruiting participants. Contact the research team at rdrad001@gmail.com for enrollment information.
Where is the NCT06478719 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06478719 clinical trial?
NCT06478719 is sponsored by Febico Biomedical Corp.. The principal investigator is Kai-Wen Huang, MD, MS, PhD at National Taiwan University Hospital. The trial plans to enroll 120 participants.
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