RecruitingPhase 1Phase 2NCT06478719

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)

Sponsor

Febico Biomedical Corp.

Enrollment

120 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests FB-1603, an experimental drug given alongside TACE (transarterial chemoembolization — a procedure that delivers chemotherapy directly to liver tumors by blocking their blood supply) in patients with hepatocellular carcinoma (liver cancer). **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed liver cancer (HCC) by imaging or biopsy - You are willing and eligible to undergo TACE - Your liver function and performance status are adequate (ECOG 0–1, Child-Pugh not severely impaired) - Your liver has evidence of fibrosis or cirrhosis (liver stiffness above 7 kPa) **You may NOT be eligible if...** - Your liver cancer is at an early stage suitable for surgery or ablation - You have severely impaired liver function - Your blood counts or organ function fall below required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.