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 (May 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
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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