Evaluating FB-1603 for liver function in liver cancer patients after 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)
This study is testing if a new treatment called FB-1603 can help improve liver function in liver cancer patients after they receive a specific type of chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Febico Biomedical Corp. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Taipei, Taiwan) |
| Trial ID | NCT06478719 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of FB-1603 in improving liver function impairment in patients with hepatocellular carcinoma who are undergoing transarterial chemoembolization (TACE). Participants will be randomly assigned to receive either FB-1603 at two different dosages or a placebo for a total of 10 weeks, with multiple follow-up visits to assess liver function parameters. The study will compare the effects of FB-1603 against a placebo to determine its effectiveness in enhancing liver function and reducing postembolization syndrome. Key outcomes include changes in liver function tests and other clinical parameters indicative of efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of hepatocellular carcinoma who are willing to undergo TACE and meet specific laboratory criteria.
Not a fit: Patients with macrovascular invasion or extrahepatic spread of cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver function and overall outcomes for patients with hepatocellular carcinoma undergoing TACE.
How similar studies have performed: While there have been studies on liver function improvement post-TACE, the specific use of FB-1603 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-75 years (inclusive) of either gender 2. Willing and able to provide signed informed consent 3. Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology 4. Subject has the willingness to undergo TACE 5. ECOG performance Status of 0-1 6. The patient is expected to survive more than 3 months 7. 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 8. With liver stiffness measurement \>7 kPa (assessed by FibroScan®) or \> 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI)) Exclusion Criteria: 1. Patients with evidence of macrovascular invasion 2. Patients with evidence of extrahepatic spread 3. Any condition representing a contraindication to TACE as determined by the investigators 4. Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, and ascites 5. 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 6. Patients who have severe organic diseases on heart, lungs, brain, kidney, and gastrointestinal tract by the judgment of investigators 7. Patients with chronic pancreatitis 8. Patients who are taking any prohibited drugs that might interfere the trial 9. Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis 10. Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit
Where this trial is running
Taipei, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Kai-Wen Huang, MD, MS, PhD — National Taiwan University Hospital
- Study coordinator: Tsung-Yen Ho, Master
- Email: rdrad001@gmail.com
- Phone: 886-2-2627-5585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.