To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
A Phase I/II Randomized, Double-blinded Study of FB-1603 to Evaluate the Safety and Efficacy in Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization (FECHT Trial)
Febico Biomedical Corp.
120 participants
Jun 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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
- 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))
Exclusion Criteria10
- 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
Interventions
Placebo oral capsule
FB-1603 (165 mg/cap) oral capsule
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06478719