Trials / Not Yet Recruiting
Not Yet RecruitingNCT07118735
AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- Sponsor
- National Cheng-Kung University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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 |
| DIETARY_SUPPLEMENT | Placebo | 3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance |
Timeline
- Start date
- 2025-08-20
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
- First posted
- 2025-08-12
- Last updated
- 2025-08-12
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT07118735. Inclusion in this directory is not an endorsement.