Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06693323
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • AHCC®capsules — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AHCC
    Oral Drug

Primary Outcome Measure

Overall Survival (OS) of Patients receiving AHCC and concurrent standard of care treatment regimens [ Time Frame: 60 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Rupali Nabar, MD
877-827-8839

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