OncoMatch/Clinical Trials/NCT06478719
To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
Is NCT06478719 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies FB-1603 for hepatocellular carcinoma.
Treatment: FB-1603 — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5×10^9/L; Hemoglobin ≥ 9 g/dL; platelet ≥ 50×10^9/L
Kidney function
Serum creatinine < 2 mg/dL
Liver function
AST, ALP and ALT ≤ 5x ULN; Total bilirubin < 2.5 mg/dL; INR ≤ 1.5; Prothrombin time < 4 sec above ULN
AST, ALP and ALT are ≤ 5x ULN. International Normalized Ratio (INR) ≤ 1.5. Prothrombin time < 4 sec above upper limit of normal. Absolute neutrophil count ≥ 1.5×10^9/L; Hemoglobin ≥ 9 g/dL; platelet ≥ 50×10^9/L. Total bilirubin < 2.5 mg/dL. Serum creatinine < 2 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06478719 currently recruiting?
Yes, this trial is currently recruiting patients.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages