Hepatocellular CarcinomaNCT07178093
Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization
A study testing Antrodia cinnamomea in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial summary
Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Transarterial Chemoembolization
- What is being tested?
- Antrodia cinnamomea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 2 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form
- Aged between 20 and 80
- Child-Pugh score class A, B
- Serum bilirubin level ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2 times the upper limit of normal
Who cannot join
- Unwillingness to sign the informed consent form
- Child-Pugh score class C
- Patients with main portal vein thrombosis
- Patients with diffuse liver tumors
- Those who are allergic to the contrast medium
- Those with abnormal coagulation function
Show all 13Show fewer
- Those with severe dysfunction of brain, heart and lung
- Patients with severe renal dysfunction (except those receiving renal dialysis)
- Unable to cooperate
- Those with uncontrolled arrhythmia and unstable blood pressure
- Some patients with abnormal thyroid function
- Any other contraindications such as active gastrointestinal bleeding, refractory ascites, or severe portal hypertension
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization
Read the detailed description
Hepatocellular carcinoma (HCC) accounts for 7% of all cancers worldwide and is the most common, primary liver malignancy globally. It is the second leading cause of cancer-related mortality in Taiwan. Most of the patients with HCCs are associated with hepatitis virus B or C infection, and combined with abnormal liver function or liver cirrhosis. The treatment of HCC includes curative treatment, including surgical resection, liver transplantation, and radiofrequency ablation. Non-curative treatment includes Transcatheter hepatic artery chemoembolization or medical therapy, such as target therapies or immunotherapies. Some patients suffered from post-TACE syndrome, e.g., abdominal pain, nausea, fever, or impaired liver function, after TACE. The clinical application was limited by the possibility of liver function deterioration. There is no standard treatment for the post-TACE syndrome currently. Therapies capable of liver protection could enhance the safety and effect of TACE.
Antrodia cinnamomea (AC) is a medicinal fungal species that has been widely used as a healthy food in Taiwan for the treatment of diverse health-related conditions, in recognition of its anticancer, hepatoprotective, anti-inflammatory, antidiabetic and neuroprotective activities. The properties of antitumor and hepatoprotective make A. cinnamomea extract or its major compounds an ideal candidate for enhancing the treatment effect for HCC.
Many cancer patients in Taiwan took Antrodia cinnamomea products during the course of therapies. In this study, we want to elucidate the effect of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization, such as the improvement of post-TACE syndrome ( liver function impairment, fever, nausea, and abdominal pain), the quality of life, and hospital stay, etc.
- Being tested
- Antrodia cinnamomea, placebo
- Keywords
- hepatocellular carcinoma (HCC), viral hepatitis, Antrodia cinnamomea, post-TACE syndrome, hepatocellular carcinoma, antrodia cinnamomea, post-TACE syndrome
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antrodia cinnamomeaDietary supplement
Also called Antrodia cinnamomea group
The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.
placeboDietary supplement
The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.
| Study group | Role | What they receive |
|---|---|---|
| Antrodia cinnamomea group | Experimental | This group will use Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage form of Antrodia cinnamomea is single capsule/500mg, each oral dose is 2 capsules/1000mg. The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time. Receives: Dietary Supplement: Antrodia cinnamomea |
| Placebo group | Placebo comparator | This group will use placebo on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage of placebo is 2 capsules twice daily. The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of serum Aspartate Transaminase (AST) level after TACE
The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
Measured: 28 days
Changes of serum Alanine Aminotransferase (ALT) level after TACE
The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
Measured: 28 days
Changes of serum total bilirubin level after TACE
The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
Measured: 28 days
Changes of serum albumin level after TACE
The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
Measured: 28 days
Changes of prothrombin time after TACE
The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline.
Measured: 28 days
Secondary outcomes (1)
Improvement of the quality of life
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30 questionnaire) has 30 items, covering both general health status and cancer-related symptoms. Each item is scored on a 4-point Likert scale (1 = "Not at all" to 4 = "Very much"), except for the global health/QoL items, which use a 7-point scale (1 = "Very poor" to 7 = "Excellent"). The differences of the scores after TACE are recorded.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Jan 2023
- Primary completion2 Oct 2026
- Study completion2 Oct 2026
Why it stopped: poor accrual and insufficient drug supply
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind placebo controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu, Cheng-Chan, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178093
- Sponsor's protocol ID
- REC111-54
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2023
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization
- ClinicalTrials.gov ID
- NCT07178093
- Acronym / sponsor ID
- REC111-54
- Keywords
- hepatocellular carcinoma (HCC), viral hepatitis, Antrodia cinnamomea, post-TACE syndrome, hepatocellular carcinoma, antrodia cinnamomea, post-TACE syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual and insufficient drug supply
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 17 Sep 2025 (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.
Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization
Detailed description
Hepatocellular carcinoma (HCC) accounts for 7% of all cancers worldwide and is the most common, primary liver malignancy globally. It is the second leading cause of cancer-related mortality in Taiwan. Most of the patients with HCCs are associated with hepatitis virus B or C infection, and combined with abnormal liver function or liver cirrhosis. The treatment of HCC includes curative treatment, including surgical resection, liver transplantation, and radiofrequency ablation. Non-curative treatment includes Transcatheter hepatic artery chemoembolization or medical therapy, such as target therapies or immunotherapies. Some patients suffered from post-TACE syndrome, e.g., abdominal pain, nausea, fever, or impaired liver function, after TACE. The clinical application was limited by the possibility of liver function deterioration. There is no standard treatment for the post-TACE syndrome currently. Therapies capable of liver protection could enhance the safety and effect of TACE.
Antrodia cinnamomea (AC) is a medicinal fungal species that has been widely used as a healthy food in Taiwan for the treatment of diverse health-related conditions, in recognition of its anticancer, hepatoprotective, anti-inflammatory, antidiabetic and neuroprotective activities. The properties of antitumor and hepatoprotective make A. cinnamomea extract or its major compounds an ideal candidate for enhancing the treatment effect for HCC.
Many cancer patients in Taiwan took Antrodia cinnamomea products during the course of therapies. In this study, we want to elucidate the effect of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization, such as the improvement of post-TACE syndrome ( liver function impairment, fever, nausea, and abdominal pain), the quality of life, and hospital stay, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double blind placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Antrodia cinnamomea group | Experimental | Dietary Supplement: Antrodia cinnamomeaThis group will use Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage form of Antrodia cinnamomea is single capsule/500mg, each oral dose is 2 capsules/1000mg. The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time. |
| Placebo group | Placebo comparator | Dietary Supplement: placeboThis group will use placebo on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage of placebo is 2 capsules twice daily. The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign the informed consent form
- Aged between 20 and 80
- Child-Pugh score class A, B
- Serum bilirubin level ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2 times the upper limit of normal
Key exclusion criteria (13 listed)
- Unwillingness to sign the informed consent form
- Child-Pugh score class C
- Patients with main portal vein thrombosis
- Patients with diffuse liver tumors
- Those who are allergic to the contrast medium
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 |
|---|---|---|
| Antrodia cinnamomeaAlso: Antrodia cinnamomea groupThe experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time. | Dietary supplement | Antrodia cinnamomea group |
| placeboThe experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time. | Dietary supplement | Placebo group |
Primary outcome
Changes of serum Aspartate Transaminase (AST) level after TACE
Time frame: 28 days
The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
Changes of serum Alanine Aminotransferase (ALT) level after TACE
Time frame: 28 days
The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
Changes of serum total bilirubin level after TACE
Time frame: 28 days
The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
Changes of serum albumin level after TACE
Time frame: 28 days
The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
Changes of prothrombin time after TACE
Time frame: 28 days
The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline.
1 secondary outcome
Improvement of the quality of life
Time frame: 28 days
Results and safety
The study was stopped early (reason given: poor accrual and insufficient drug supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antrodia cinnamomea in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Taichung Tzu Chi Hospital at 1 site 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: poor accrual and insufficient drug supply). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of serum Aspartate Transaminase (AST) level after TACE (time frame: 28 days). The study lists 5 primary outcomes in all. 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 6 Oct 2026.