NCT06478719

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Febico Biomedical Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed description

I. Objectives: * Primary objective: To assess the efficacy of FB-1603 on improving liver function impairment after transarterial chemoembolization (TACE) in subjects * Secondary objective: * To evaluate the safety of FB-1603 in subjects * To evaluate selected parameters indicative of clinical efficacy * To assess postembolization syndrome improvement of FB-1603 compared with placebo * To evaluate virologic test level of FB-1603 compared with placebo * To assess liver stiffness change of FB-1603 compared with placebo * Exploratory objective: * To assess the antioxidation activity of FB-1603 in hepatocellular carcinoma (HCC) subjects after TACE II. Investigational product: 1. Name: FB-1603 oral capsule (FB-1603) 2. Dosage form: 165 mg oral capsule 3. Dose(s): Each arm consisted of 40 subjects. * Arm 1: 4\*Placebo each time, TID (three times a Day), two weeks before and eight weeks after TACE * Arm 2: 2\*FB-1603 165 mg oral capsule and 2\*Placebo each time, TID (990 mg/day), two weeks before and eight weeks after TACE * Arm 3: 4\*FB-1603 165 mg oral capsule each time, TID (1980 mg/day), two weeks before and eight weeks after TACE 4. Dosing schedule: All enrolled subjects will be randomly assigned (1:1:1) to receive low dose (990 mg/day), high dose (1980 mg/day) of FB-1603 165 mg oral capsule or placebo capsule three times a day for 10 weeks. Each subject starts receiving FB-1603 165 mg oral capsule or placebo capsule on two weeks before and eight weeks after TACE. The investigational drugs should be taken orally about 10 minutes before the breakfast, lunch, and dinner 5. Mechanism of action: The proposed mechanism is that FB-1603 can improve liver function via decrease of oxidative stress. In previous study conducted in diethylnitrosamine (DEN) induced liver cirrhosis and cancer rat model (Report #: FENTU30SEP2009) shown that the extent of oxidative stress determined by NBT (Nitro blue tetrazolium) staining was significant decreased in treatment group orally administrated with 0.8, 1 or 2 g/kg/day of FB-1603 compared with the control group. III. Developmental phase: phase I and II IV. Study design: 1. placebo control study 2. Blinding: double blind 3. Randomized: yes 4. Parallel 5. Duration of treatment: days 10 weeks months years 6. Titration: forced 7. Single center VI. Study procedures: This is a randomized, double-blind, 10-week dose-finding study in 3 parallel arms. The study is conducted as follows: eligible subjects are randomized parallelly into 3 arms. Each arm comprises 40 subjects orally receive active (FB-1603 165 mg oral capsule) or placebo (placebo capsule) two weeks before and eight weeks after TACE. Each subject will begin receiving FB-1603 oral capsule or placebo two weeks before TACE. As the appearance of the placebo capsule is identical to the FB-1603 165 mg oral capsule, study blinding will be maintained during the administration procedure. Other than staff involved in randomization, the sponsor, participants, and staff involved in the preparation of the study drug are blinded. Each subject is assigned to either active (FB-1603 165 mg oral capsule) or placebo treatment using a block randomization algorithm. Three times a day (TID) doses of FB-1603 165 mg oral capsule are escalated capsule low dose (990 mg/day) and high dose (1980 mg/day).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Placebo	Placebo oral capsule
DRUG	FB-1603	FB-1603 (165 mg/cap) oral capsule

Timeline

• Start date: 2024-06-24
• Primary completion: 2027-06-07
• Completion: 2027-08-06
• First posted: 2024-06-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: Taiwan