AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy
NCT ID: NCT07118735
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
94 participants
INTERVENTIONAL
2025-08-20
2028-12-31
Brief Summary
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Detailed Description
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Assess the potential of AHCC® to improve immunotherapy outcomes Evaluate progression-free survival (PFS) Evaluate overall survival (OS) Assess safety and tolerability
Method:
Participants will take 3 grams of AHCC® or placebo orally each day Treatment will continue until disease progression, treatment intolerance or other treatment options become available.
Note:
AHCC® is a novel functional food with immune-modulating potential.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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participants receive oral administration of 3g AHCC® daily
3 grams of AHCC taken orally once daily until disease progression or intolerance
A standardized extract of cultured Lentinula edodes mycelia (AHCC®)
3 grams of AHCC® taken orally once daily for 6 months or until disease progression or intolerance
Placebo
3 grams of dextrin (placebo) taken orally once daily until disease progression or intolerance
Placebo
3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance
Interventions
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A standardized extract of cultured Lentinula edodes mycelia (AHCC®)
3 grams of AHCC® taken orally once daily for 6 months or until disease progression or intolerance
Placebo
3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yih-Jyh Lin
Role: PRINCIPAL_INVESTIGATOR
National Cheng Kung University Hospital (NCKUH)
Locations
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No. 138, Shengli Rd., North Dist
Tainan City, , Taiwan
Countries
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Central Contacts
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References
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Matsui Y, Uhara J, Satoi S, Kaibori M, Yamada H, Kitade H, Imamura A, Takai S, Kawaguchi Y, Kwon AH, Kamiyama Y. Improved prognosis of postoperative hepatocellular carcinoma patients when treated with functional foods: a prospective cohort study. J Hepatol. 2002 Jul;37(1):78-86. doi: 10.1016/s0168-8278(02)00091-0.
Spierings EL, Fujii H, Sun B, Walshe T. A Phase I study of the safety of the nutritional supplement, active hexose correlated compound, AHCC, in healthy volunteers. J Nutr Sci Vitaminol (Tokyo). 2007 Dec;53(6):536-9. doi: 10.3177/jnsv.53.536.
Daddaoua A, Martinez-Plata E, Lopez-Posadas R, Vieites JM, Gonzalez M, Requena P, Zarzuelo A, Suarez MD, de Medina FS, Martinez-Augustin O. Active hexose correlated compound acts as a prebiotic and is antiinflammatory in rats with hapten-induced colitis. J Nutr. 2007 May;137(5):1222-8. doi: 10.1093/jn/137.5.1222.
Park HJ, Boo S, Park I, Shin MS, Takahashi T, Takanari J, Homma K, Kang I. AHCC(R), a Standardized Extract of Cultured Lentinula Edodes Mycelia, Promotes the Anti-Tumor Effect of Dual Immune Checkpoint Blockade Effect in Murine Colon Cancer. Front Immunol. 2022 Apr 20;13:875872. doi: 10.3389/fimmu.2022.875872. eCollection 2022.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NationalCheng-KungU
Identifier Type: REGISTRY
Identifier Source: secondary_id
B-BR-114-016
Identifier Type: -
Identifier Source: org_study_id
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