To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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)

Key facts

Study ID: NCT06478719
Run by: Febico Biomedical Corp.
People needed: 120
Starts: 2024-06-24
Expected to finish: 2028-08-06
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged 18-85 years (inclusive) of either gender
Willing and able to provide signed informed consent
Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology
Subject has the willingness to undergo TACE
ECOG performance Status of 0-1
The patient is expected to survive more than 3 months
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
With liver stiffness measurement >7 kPa (assessed by FibroScan®) or > 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI))

You may not qualify if…

Patients with evidence of macrovascular invasion
Patients with evidence of extrahepatic spread
Any condition representing a contraindication to TACE as determined by the investigators
Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, and ascites
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
Patients who have severe organic diseases on heart, lungs, brain, kidney, and gastrointestinal tract by the judgment of investigators
Patients with chronic pancreatitis
Patients who are taking any prohibited drugs that might interfere the trial
Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis
Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit

Where it is running

National Taiwan University Hospital — Taipei, Taiwan, Taiwan (enrolling)
Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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