AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy

Официальное название

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

Обзор

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.

Подробное описание

Objectives:

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.

Вмешательства

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

Первичные конечные точки

• Objective Response Rate (ORR) as assessed by RECIST v1.1 [Срок оценки: Every 12 weeks up to 24 months]

Вторичные конечные точки (6)

• Progression-Free Survival (PFS) as assessed by RECIST v1.1 [Срок оценки: Up to 24 months]
• Overall Survival (OS) [Срок оценки: Up to 36 months]
• Number of participants experiencing any grade adverse events (AEs) as assessed by CTCAE v4.0 [Срок оценки: Every 3 weeks during treatment, up to 24 months]
• Number of participants experiencing serious adverse events (SAEs) as defined by regulatory criteria [Срок оценки: Throughout study participation, up to 24 months]
• Change in quality of life measured by EORTC QLQ-C30 [Срок оценки: Baseline and every 12 weeks, up to 24 months]
• Change in hepatocellular carcinoma-specific quality of life measured by EORTC QLQ-HCC18 [Срок оценки: Baseline and every 12 weeks, up to 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• No. 138, Shengli Rd., North Dist — Tainan

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07118735 · B-BR-114-016 · NationalCheng-KungU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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