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NCT Number: NCT07178093

Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization

Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Tzu-Chi Hospital

Taichung, Taiwan, 406

Location status: Recruiting

Location contact

Cheng-Chan Yu, Dr

CONTACT

[email protected]

+886-4-36060666 ext. 3040

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Antrodia cinnamomea

Dietary Supplement

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.

Other names: Antrodia cinnamomea group

Placebo

Dietary 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

Secondary outcomes

  1. Improvement of the quality of life

    Time frame: 28 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Cheng-Chan, Dr

CONTACT

[email protected]

+886-0436060666 ext. 3040

Yu Cheng-Chan, MD

CONTACT

[email protected]

+886-0436060666 ext. 3040

Sponsors and collaborators

Lead sponsor

Taichung Tzu Chi Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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