Actively Recruiting
Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC
Led by University of California, Irvine · Updated on 2025-03-27
34
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2, single-arm, open-label clinical trial determining safety and tolerability of AHCC in subjects with HPV-positive patients with Head and Neck Squamous Cell Carcinoma. These are subjects who have undergone surgery or will be undergoing surgery.
CONDITIONS
Official Title
Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 79 years of age.
- Diagnosed with HPV-positive Head and Neck Squamous Cell Carcinoma.
- Registered at least 4 weeks after surgery if surgery has been done.
- High-risk disease after surgery defined by positive margins or extra nodal extension.
- No evidence of distant disease (M0) on imaging within 28 days before registration.
- ECOG Performance Status of 0 or 1.
- Able to understand and willing to sign informed consent (or have authorized representative).
- Females of childbearing potential must test negative for pregnancy within 14 days before registration.
- Women of childbearing potential and sexually active males must use effective contraception or abstain during treatment and for 120 days after.
- Adequate organ and marrow function based on recent laboratory tests.
You will not qualify if you...
- Pregnant or breastfeeding.
- Active infection requiring systemic treatment at registration.
- History of solid organ or stem cell transplant.
- Taking immunosuppressive medication within 7 days before registration, except certain steroids.
- New York Heart Association Class III or IV heart failure.
- Received live vaccine within 30 days before first study drug dose.
- Known history of Hepatitis B or active Hepatitis C infection.
- History of HIV with recent detectable viral loads or related diseases.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- Allergy to mushrooms or components of the study drug.
- Psychiatric or substance abuse disorder interfering with study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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