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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
94
3 grams of AHCC® taken orally once daily for 6 months or until disease progression or intolerance
3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance
No. 138, Shengli Rd., North Dist
Tainan, Taiwan
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).
Time frame: Every 12 weeks up to 24 months
Progression-Free Survival (PFS) as assessed by RECIST v1.1
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.
Time frame: Up to 24 months
Overall Survival (OS)
OS is defined as the time from initiation of study treatment to death from any cause.
Time frame: Up to 36 months
Number of participants experiencing any grade adverse events (AEs) as assessed by CTCAE v4.0
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.
Time frame: Every 3 weeks during treatment, up to 24 months
Number of participants experiencing serious adverse events (SAEs) as defined by regulatory criteria
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.
Time frame: Throughout study participation, up to 24 months
Change in quality of life measured by EORTC QLQ-C30
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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.
Time frame: Baseline and every 12 weeks, up to 24 months
Change in hepatocellular carcinoma-specific quality of life measured by EORTC QLQ-HCC18
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.
Time frame: Baseline and every 12 weeks, up to 24 months