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AHCC for Head and Neck Squamous Cell Carcinoma

Phase 2

Waitlist Available

Led By Rupali Nabar, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Between 18 and 79 years of age.

* Has a diagnosis of pathologically or cytologically proven HPV positive HNSCC.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS) of Patients receiving AHCC and concurrent standard of care treatment regimens

Secondary study objectives

Difference in Tumor Response of patients receiving concurrent therapy with chemoradiation plus AHCC over SoC treatment and in the long term follow up period compared to historical data.

Percentage of Adverse Events

Other study objectives

Change in Quality of Life (QoL) score

Changes in HPV DNA in blood samples from HPV+ patients with HNSCC