To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transart… (NCT06478719) | Clinical Trial Compass
RecruitingPhase 1/2
To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
Taiwan120 participantsStarted 2024-06-24
Plain-language 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)
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. With liver stiffness measurement \>7 kPa (assessed by FibroScan®) or \> 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI))
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the level of liver function
Timeframe: from baseline (day 0) to Visit 3 (day 4), Visit 4(day 7), Visit 5(day 10), and Visit 6(day 14)
. 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