AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy

NCT07118735 | Not Yet Recruiting DMC

• 2 other identifiers: B-BR-114-016NationalCheng-KungU
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, double-blind, randomized, placebo-controlled trial to evaluate whether AHCC® (Active Hexose Correlated Compound) can enhance the effect of immunotherapy in liver cancer patients.

Conditions

Liver Cancer; Hepatocellular Carcinoma

Keywords

AHCC® (Active Hexose Correlated Compound); immunotherapy; liver cancer; functional food

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as assessed by RECIST v1.1

  Tumor response will be assessed by imaging (CT scan preferred) every 12 weeks using RECIST version 1.1 criteria. Objective Response Rate (ORR) is defined as the proportion of participants achieving a Complete Response (CR) or Partial Response (PR).

  Every 12 weeks up to 24 months

Secondary Outcomes (6)

• Progression-Free Survival (PFS) as assessed by RECIST v1.1

  Up to 24 months

• Overall Survival (OS)

  Up to 36 months

• Number of participants experiencing any grade adverse events (AEs) as assessed by CTCAE v4.0

  Every 3 weeks during treatment, up to 24 months

• Number of participants experiencing serious adverse events (SAEs) as defined by regulatory criteria

  Throughout study participation, up to 24 months

• Change in quality of life measured by EORTC QLQ-C30

  Baseline and every 12 weeks, up to 24 months

Study Arms (2)

participants receive oral administration of 3g AHCC® daily

EXPERIMENTAL

3 grams of AHCC taken orally once daily until disease progression or intolerance

Dietary Supplement: A standardized extract of cultured Lentinula edodes mycelia (AHCC®)

Placebo

PLACEBO COMPARATOR

3 grams of dextrin (placebo) taken orally once daily until disease progression or intolerance

Dietary Supplement: Placebo

Interventions

A standardized extract of cultured Lentinula edodes mycelia (AHCC®) DIETARY_SUPPLEMENT

3 grams of AHCC® taken orally once daily for 6 months or until disease progression or intolerance

participants receive oral administration of 3g AHCC® daily

Placebo DIETARY_SUPPLEMENT

3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance

Also known as: dextrin

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cancer patient who will receive immunotherapy
• At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
• Age \>=20 years old.
• ECOG performance status 0 or 1.
• White blood count \>=2,000/microliter ; platelet count \>=60,000/microliter.
• 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).
• 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.

You may not qualify if:

• Major systemic diseases that the investigator considers inappropriate for participation.
• 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.
• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
• 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).
• 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.
• Prior organ allograft or allogeneic bone marrow transplantation.
• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

No. 138, Shengli Rd., North Dist

Tainan, 704, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 12076865 RESULT

• 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.

  PMID: 18202543 RESULT

• 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.

  PMID: 17449585 RESULT

• 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.

  PMID: 35514996 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Dextrins

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Yih-Jyh Lin

  National Cheng Kung University Hospital (NCKUH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Yeh Su

CONTACT

+886 67000123; yysu@nhri.edu.tw

Chien-Chi Shen

CONTACT

+886 62353535; shenlala69@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective double-blind, randomized, placebo-controlled trial aims to investigate whether add-on of a standardized extract of cultured Lentinula edodes mycelia (AHCC®) can enhance the effect of immunotherapy in cancer patients.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 12, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)