AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy

Launched by NATIONAL CHENG-KUNG UNIVERSITY HOSPITAL · Aug 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a natural supplement called AHCC® can help boost the effects of immunotherapy in people with liver cancer, specifically a type called hepatocellular carcinoma. Immunotherapy is a treatment that helps the body’s immune system fight cancer. The study will compare patients who take AHCC® with those who take a placebo (a harmless pill with no active ingredients) to see if AHCC® improves the treatment’s success.

People who might be eligible for this trial are adults 20 years or older who have liver cancer and are about to start immunotherapy. They need to have at least one tumor that can be measured and hasn’t been treated with local procedures like surgery or radiation. Participants should be in generally good health with certain blood counts and liver function within safe limits. People with some controlled autoimmune conditions or chronic hepatitis B (who start antiviral medication before the study) may also qualify. Those who have had previous immunotherapy treatments, serious autoimmune diseases, or certain other health issues will not be eligible. Participants can expect to be randomly assigned to take either AHCC® or a placebo without knowing which one they receive, and their response to immunotherapy will be carefully monitored. This study has not started recruiting yet, so if you or a loved one fits these criteria and are interested, keep an eye out for updates from your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.Liver cancer patient who will receive immunotherapy
• • 2.At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
• • 3.Age \>=20 years old.
• • 4.ECOG performance status 0 or 1.
• • 5.White blood count \>=2,000/microliter ; platelet count \>=60,000/microliter.
• • 6.Liver transaminases (ALT and AST) \<=5 times upper limit of normal values (ULN); total bilirubin \<= 2 times ULN; creatinine clearance or eGFR \> 50 mL/min (either Cockcroft-Gault or MDRD is acceptable, whichever is higher).
• • 7.Subjects with chronic hepatitis B virus infection (HBV surface antigen (HBsAg) positive) must start antiviral therapy with nucleoside analogs (e.g., entecavir or tenofovir, according to current practice guidelines) before start of study drug treatment.
• Exclusion Criteria:
• • 1.Major systemic diseases that the investigator considers inappropriate for participation.
• • 2.Any active autoimmune disease or history of known autoimmune disease except for vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• • 3.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
• • 4.Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
• • 5.Requirement of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• • 6.Prior organ allograft or allogeneic bone marrow transplantation.
• • 7.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.