Hepatocellular CarcinomaPhase 1/2NCT06478719
To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
A Phase 1/2 study testing FB-1603 in people with Hepatocellular Carcinoma, run by Febico Biomedical Corp. at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- FB-1603
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 24 Jun 2024to 6 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Laboratory values should meet all the following standards at the screening visit:
- 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.
- 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))
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
Kai-Wen Huang, MD, MS, PhD, 886-2-2312-3456 ext. 66144, skywing@ntuh.gov.tw
Kai-Wen Huang, MD, MS, PhD
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Shi-Ming Lin, P.h.D, 8863-3281200#8107, lsmpaicyto@cgmh.org.tw
About this study
Official title: 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)
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
- Take drug FB-1603 990mg/day, FB-1603 1980mg/day or a placebo every day for 10 weeks.
- Visit the clinic on day 4, 7, 10, 14, 28, 56 and 84 (follow-up)
Read the detailed description
- 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:
- Name: FB-1603 oral capsule (FB-1603)
- Dosage form: 165 mg oral capsule
- 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
- 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
- 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:
- placebo control study
- Blinding: double blind
- Randomized: yes
- Parallel
- Duration of treatment: days 10 weeks months years
- Titration: forced
- 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
- Being tested
- Placebo, FB-1603
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo oral capsule
FB-1603Drug
FB-1603 (165 mg/cap) oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: 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. Receives: Drug: FB-1603 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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
Changes in the level of liver function parameters, including AST, ALT, or total bilirubin after TACE
Measured: from baseline (day 0) to Visit 7 (day 28) and Visit 8 (day 56)
Frequency and severity of adverse event (AE) during the study
Assessment of frequency and severity of adverse event (AE) during the study
Measured: up to 84 days
Clinically significant changes in blood chemistry
Clinically significant changes in blood chemistry at each applicable visit
Measured: 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
Clinically significant changes in coagulation test at each applicable visit including international normalized ratio (INR) and prothrombin time.
Measured: 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)
Changes in measurements of indocyanine green retention (ICG) test at each applicable visit
Measured: from baseline (day 0) to Visit 3 (day 4) and Visit 5 (day 10)
Level of liver fibrosis
Level of liver fibrosis by elastography and fibrosis-4 (FIB-4) index
Measured: at the screening visit (day -28 to -15), Visit 8 (day 56) and FV/ET (day 84)
Incidence of postembolization syndrome
Incidence of postembolization syndrome
Measured: 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) and Visit 8 (day 56)
Length of hospital stay after TACE
Length of hospital stay after TACE
Measured: Visit 2 (day 0)
Changes in the level of quantitative HBsAg or HCV RNA
Changes in the level of quantitative HBsAg or HCV RNA measured by PCR
Measured: from screening visit (day -28 to -15) to Visit 8 (day 56) and FV/ET (day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start24 Jun 2024
- Primary completion7 Jun 2028 (estimated)
- Study completion6 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Febico Biomedical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, MD, MS, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478719
- Sponsor's protocol ID
- FB-1603_TACE_PII_2022_1
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06478719
- Acronym / sponsor ID
- FB-1603_TACE_PII_2022_1
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Febico Biomedical Corp.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 7 Jun 2028 (estimated)
- Study completion
- 6 Aug 2028 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Take drug FB-1603 990mg/day, FB-1603 1980mg/day or a placebo every day for 10 weeks.
- Visit the clinic on day 4, 7, 10, 14, 28, 56 and 84 (follow-up)
Detailed description
- 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:
- Name: FB-1603 oral capsule (FB-1603)
- Dosage form: 165 mg oral capsule
- 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
- 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
- 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:
- placebo control study
- Blinding: double blind
- Randomized: yes
- Parallel
- Duration of treatment: days 10 weeks months years
- Titration: forced
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo4*Placebo oral capsule each time, TID (three times a Day). treatment period: start two weeks before TACE until eight weeks after TACE. |
| low dose FB-1603 (990mg/day) | Experimental | Drug: Placebo, Drug: FB-16032*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. |
| high dose FB-1603 (1980mg/day) | Experimental | Drug: FB-16034*FB-1603 165 mg oral capsule each time, TID (1980 mg/day). treatment period: start two weeks before TACE until eight weeks after TACE. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo oral capsule | Drug | low dose FB-1603 (990mg/day), placebo |
| FB-1603FB-1603 (165 mg/cap) oral capsule | Drug | high dose FB-1603 (1980mg/day), low dose FB-1603 (990mg/day) |
Primary outcome
Changes in the level of liver function
Time frame: from baseline (day 0) to Visit 3 (day 4), Visit 4(day 7), Visit 5(day 10), and Visit 6(day 14)
Changes in the level of liver function parameters, including aspartate transferase (AST), alanine transferase (ALT), or total bilirubin,
9 secondary outcomes
Changes in the level of liver function
Time frame: from baseline (day 0) to Visit 7 (day 28) and Visit 8 (day 56)
Frequency and severity of adverse event (AE) during the study
Time frame: up to 84 days
Clinically significant changes in blood chemistry
Time frame: 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
Time frame: 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)
Time frame: from baseline (day 0) to Visit 3 (day 4) and Visit 5 (day 10)
Level of liver fibrosis
Time frame: at the screening visit (day -28 to -15), Visit 8 (day 56) and FV/ET (day 84)
Incidence of postembolization syndrome
Time frame: 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) and Visit 8 (day 56)
Length of hospital stay after TACE
Time frame: Visit 2 (day 0)
Changes in the level of quantitative HBsAg or HCV RNA
Time frame: from screening visit (day -28 to -15) to Visit 8 (day 56) and FV/ET (day 84)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai-Wen Huang, MD, MS, PhD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FB-1603 in people with Hepatocellular Carcinoma, run by Febico Biomedical Corp. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsung-Yen Ho, Master (886-2-2627-5585 ext. 116, rdrad001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of liver function (time frame: from baseline (day 0) to Visit 3 (day 4), Visit 4(day 7), Visit 5(day 10), and Visit 6(day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.