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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) as assessed by RECIST v1.1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
participants receive oral administration of 3g AHCC® daily
3 grams of AHCC taken orally once daily until disease progression or intolerance
干预措施: A standardized extract of cultured Lentinula edodes mycelia (AHCC®) (Dietary Supplement)
Placebo
3 grams of dextrin (placebo) taken orally once daily until disease progression or intolerance
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Objective Response Rate (ORR) as assessed by RECIST v1.1
时间窗: Every 12 weeks up to 24 months
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).
次要结局
- Overall Survival (OS)(Up to 36 months)
- Change in quality of life measured by EORTC QLQ-C30(Baseline and every 12 weeks, up to 24 months)
- Change in hepatocellular carcinoma-specific quality of life measured by EORTC QLQ-HCC18(Baseline and every 12 weeks, up to 24 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)
- Progression-Free Survival (PFS) as assessed by RECIST v1.1(Up to 24 months)