Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
AHCC® (Active Hexose Correlated Compound), immunotherapy, liver cancer, functional food
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTA 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
DIETARY_SUPPLEMENTPlacebo
3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) as assessed by RECIST v1.1 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 36 months | OS is defined as the time from initiation of study treatment to death from any cause. |
| Number of participants experiencing any grade adverse events (AEs) as assessed by CTCAE v4.0 | Every 3 weeks during treatment, up to 24 months | 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. |
| Progression-Free Survival (PFS) as assessed by RECIST v1.1 | Up to 24 months | 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. |
| Change in quality of life measured by EORTC QLQ-C30 | Baseline and every 12 weeks, up to 24 months | 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). Scores range from 0 to 100. Higher scores on global health and functional scales indicate better functioning; higher scores on symptom scales indicate worse symptoms. |
| Change in hepatocellular carcinoma-specific quality of life measured by EORTC QLQ-HCC18 | Baseline and every 12 weeks, up to 24 months | 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. Each scale/item is scored from 0 to 100. Higher scores indicate worse symptoms or problems. |
| Number of participants experiencing serious adverse events (SAEs) as defined by regulatory criteria | Throughout study participation, up to 24 months | 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. |
Countries
Taiwan
Contacts
Primary ContactYung-Yeh Su
Backup ContactChien-Chi Shen
Outcome results
None listed