NCT06478719

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. 1.Take drug FB-1603 990mg/day, FB-1603 1980mg/day or a placebo every day for 10 weeks.
  2. 2.Visit the clinic on day 4, 7, 10, 14, 28, 56 and 84 (follow-up)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
24mo left

Started Jun 2024

Typical duration for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jun 2024Aug 2028

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2028

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

June 17, 2024

Last Update Submit

July 14, 2026

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Changes in the level of liver function

    Changes in the level of liver function parameters, including aspartate transferase (AST), alanine transferase (ALT), or total bilirubin,

    from baseline (day 0) to Visit 3 (day 4), Visit 4(day 7), Visit 5(day 10), and Visit 6(day 14)

Secondary Outcomes (9)

  • Changes in the level of liver function

    from baseline (day 0) to Visit 7 (day 28) and Visit 8 (day 56)

  • Frequency and severity of adverse event (AE) during the study

    up to 84 days

  • Clinically significant changes in blood chemistry

    from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28), Visit 8 (day 56) and follow-up visit (day 84)

  • Clinically significant changes in coagulation test

    from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28), Visit 8 (day 56) and follow-up visit (day 84)

  • Changes in measurements of indocyanine green retention (ICG)

    from baseline (day 0) to Visit 3 (day 4) and Visit 5 (day 10)

  • +4 more secondary outcomes

Study Arms (3)

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

low dose FB-1603 (990mg/day)

EXPERIMENTAL

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.

Drug: PlaceboDrug: FB-1603

high dose FB-1603 (1980mg/day)

EXPERIMENTAL

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.

Drug: FB-1603

Interventions

PlaceboDRUG

Placebo oral capsule

low dose FB-1603 (990mg/day)placebo
FB-1603DRUG

FB-1603 (165 mg/cap) oral capsule

high dose FB-1603 (1980mg/day)low dose FB-1603 (990mg/day)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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
  • With liver stiffness measurement \>7 kPa (assessed by FibroScan®) or \> 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI))

You may not qualify if:

  • 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
  • Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis
  • Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan, 10002, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kai-Wen Huang, MD, MS, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsung-Yen Ho, Master

CONTACT

886-2-2627-5585rdrad001@gmail.com

Jyun-Yuan Huang, Doctor

CONTACT

886-2-2627-5585jyhuang@febico.com.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 27, 2024

Study Start

June 24, 2024

Primary Completion (Estimated)

June 7, 2028

Study Completion (Estimated)

August 6, 2028

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

TW(2)