AHCC® as Immune Modulator in Cancer Patients Treated With Immunotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng-Kung University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
A standardized extract of cultured Lentinula edodes mycelia (AHCC®)
Dietary supplement3 grams of AHCC® taken orally once daily for 6 months or until disease progression or intolerance
Placebo
Dietary supplement3 grams of dextrin (placebo) taken orally once daily for 6 months or until disease progression or intolerance
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: participants receive oral administration of 3g AHCC® dailyExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
Overall Survival (OS)
OS is defined as the time from initiation of study treatment to death from any cause.
Time frame
Up to 36 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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