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
Qualifiers
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
Treatments tested in this trial
- A standardized extract of cultured Lentinula edodes mycelia (AHCC®)
- Placebo
Treatment groups
94 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov