To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization

NCT ID: NCT06478719

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2027-08-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

4\*Placebo oral capsule each time, TID (three times a Day). treatment period: start two weeks before TACE until eight weeks after TACE.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral capsule

low dose FB-1603 (990mg/day)

2\*FB-1603 165 mg oral capsule and 2\*Placebo oral capsule each time, TID (990 mg/day). treatment period: start two weeks before TACE until eight weeks after TACE.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo oral capsule

FB-1603

Intervention Type: DRUG

FB-1603 (165 mg/cap) oral capsule

high dose FB-1603 (1980mg/day)

4\*FB-1603 165 mg oral capsule each time, TID (1980 mg/day). treatment period: start two weeks before TACE until eight weeks after TACE.

Group Type: EXPERIMENTAL

FB-1603

Intervention Type: DRUG

FB-1603 (165 mg/cap) oral capsule

Interventions

Placebo

Placebo oral capsule

Intervention Type: DRUG

FB-1603

FB-1603 (165 mg/cap) oral capsule

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Febico Biomedical Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai-Wen Huang, MD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tsung-Yen Ho, Master

Role: CONTACT

rdrad001@gmail.com

886-2-2627-5585 ext. 116

Jyun-Yuan Huang, Doctor

Role: CONTACT

jyhuang@febico.com.tw

886-2-2627-5585 ext. 111

Facility Contacts

Kai-Wen Huang, MD, MS, PhD

Role: primary

skywing@ntuh.gov.tw

886-2-2312-3456 ext. 66144

Other Identifiers

FB-1603_TACE_PII_2022_1

Identifier Type: -

Identifier Source: org_study_id