Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06478719

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

Led by Febico Biomedical Corp. · Updated on 2025-02-27

120

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

F

Febico Biomedical Corp.

Lead Sponsor

N

National Taiwan University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-75 years (inclusive) of either gender
  • Willing and able to provide signed informed consent
  • Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology
  • Willingness to undergo transarterial chemoembolization (TACE)
  • ECOG performance status of 0-1
  • Expected survival of more than 3 months
  • Laboratory values at screening: AST, ALP, ALT  5 times upper limit of normal; INR  1.5; prothrombin time < 4 seconds above upper limit of normal; absolute neutrophil count  1.5 x 10^9/L; hemoglobin  9 g/dL; platelet count  50 x 10^9/L; total bilirubin < 2.5 mg/dL; serum creatinine < 2 mg/dL
  • Liver stiffness measurement > 7 kPa by FibroScan4 or > 1.5 m/sec by acoustic radiation force impulse elastography (ARFI)
Not Eligible

You will not qualify if you...

  • Evidence of macrovascular invasion
  • Evidence of extrahepatic spread
  • Any condition contraindicating TACE as determined by investigators
  • Acute liver failure or liver function decompensation, such as hepatic encephalopathy and ascites
  • Acute or chronic active hepatitis B or C infection recommended for treatment (e.g., HBV DNA  20,000 IU/ml or detectable HCV RNA)
  • Severe organic diseases of heart, lungs, brain, kidney, or gastrointestinal tract
  • Chronic pancreatitis
  • Use of prohibited drugs that might interfere with the trial
  • Inability to express chief complaints due to psychosis or severe neurosis
  • Active infections requiring systemic antibiotics within 4 weeks prior to screening

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, Taiwan, 10002

Actively Recruiting

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Research Team

T

Tsung-Yen Ho, Master

CONTACT

J

Jyun-Yuan Huang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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