Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT07118735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003912', 'term': 'Dextrins'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-23', 'size': 990827, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-24T05:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as assessed by RECIST v1.1', 'timeFrame': 'Every 12 weeks up to 24 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) as assessed by RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'PFS is defined as the time from the start of treatment to the first documentation of disease progression or death from any cause, whichever occurs first. Tumor response will be assessed using RECIST version 1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 36 months', 'description': 'OS is defined as the time from initiation of study treatment to death from any cause.'}, {'measure': 'Number of participants experiencing any grade adverse events (AEs) as assessed by CTCAE v4.0', 'timeFrame': 'Every 3 weeks during treatment, up to 24 months', 'description': "Adverse events will be collected and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Events of any grade will be recorded throughout the study."}, {'measure': 'Number of participants experiencing serious adverse events (SAEs) as defined by regulatory criteria', 'timeFrame': 'Throughout study participation, up to 24 months', 'description': 'SAEs will be recorded and reported according to ICH and local regulatory definitions, including events such as death, life-threatening conditions, hospitalization, disability, or other medically significant events.'}, {'measure': 'Change in quality of life measured by EORTC QLQ-C30', 'timeFrame': 'Baseline and every 12 weeks, up to 24 months', 'description': 'Quality of life will be assessed using the EORTC QLQ-C30, which evaluates global health status, five functional scales (physical, role, emotional, cognitive, and social), and multiple cancer-related symptoms (e.g., fatigue, pain, nausea).\n\nScores range from 0 to 100. Higher scores on global health and functional scales indicate better functioning; higher scores on symptom scales indicate worse symptoms.'}, {'measure': 'Change in hepatocellular carcinoma-specific quality of life measured by EORTC QLQ-HCC18', 'timeFrame': 'Baseline and every 12 weeks, up to 24 months', 'description': 'The EORTC QLQ-HCC18 will be used to assess liver cancer-specific symptoms and concerns, including fatigue, body image, nutrition, pain, jaundice, abdominal swelling, and fever.\n\nEach scale/item is scored from 0 to 100. Higher scores indicate worse symptoms or problems.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AHCC® (Active Hexose Correlated Compound)', 'immunotherapy', 'liver cancer', 'functional food'], 'conditions': ['Liver Cancer', 'Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '12076865', 'type': 'RESULT', 'citation': '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': '18202543', 'type': 'RESULT', 'citation': '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': '17449585', 'type': 'RESULT', 'citation': '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': '35514996', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Objectives:\n\nAssess the potential of AHCC® to improve immunotherapy outcomes Evaluate progression-free survival (PFS) Evaluate overall survival (OS) Assess safety and tolerability\n\nMethod:\n\nParticipants 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.\n\nNote:\n\nAHCC® is a novel functional food with immune-modulating potential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Liver cancer patient who will receive immunotherapy\n* 2.At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.\n* 3.Age \\>=20 years old.\n* 4.ECOG performance status 0 or 1.\n* 5.White blood count \\>=2,000/microliter ; platelet count \\>=60,000/microliter.\n* 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).\n* 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.\n\nExclusion Criteria:\n\n* 1.Major systemic diseases that the investigator considers inappropriate for participation.\n* 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.\n* 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.\n* 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).\n* 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.\n* 6.Prior organ allograft or allogeneic bone marrow transplantation.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07118735', 'acronym': 'NCKUH', 'briefTitle': 'AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'A Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) as Immune Modulator in Cancer Patients Treated With Immunotherapy: a Phase 2 Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'B-BR-114-016'}, 'secondaryIdInfos': [{'id': 'NationalCheng-KungU', 'type': 'REGISTRY', 'domain': 'National Cheng-Kung University Hospital Clinical Trial Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'participants receive oral administration of 3g AHCC® daily', 'description': '3 grams of AHCC taken orally once daily until disease progression or intolerance', 'interventionNames': ['Dietary Supplement: A standardized extract of cultured Lentinula edodes mycelia (AHCC®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '3 grams of dextrin (placebo) taken orally once daily until disease progression or intolerance', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'A standardized extract of cultured Lentinula edodes mycelia (AHCC®)', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 grams of AHCC® taken orally once daily for 6 months or until disease progression or intolerance', 'armGroupLabels': ['participants receive oral administration of 3g AHCC® daily']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['dextrin'], 'description': '3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'No. 138, Shengli Rd., North Dist', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Yung-Yeh Su', 'role': 'CONTACT', 'email': 'yysu@nhri.edu.tw', 'phone': '+886 67000123', 'phoneExt': '65181'}, {'name': 'Chien-Chi Shen', 'role': 'CONTACT', 'email': 'shenlala69@gmail.com', 'phone': '+886 62353535', 'phoneExt': '5207'}], 'overallOfficials': [{'name': 'Yih-Jyh Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng Kung University Hospital (NCKUH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}