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Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC)

NCT06097468 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-13

No results posted yet for this study

Summary

This is a study of oral nisin administration in patients with OSCC who are undergoing complete surgical resection surgery with or without adjuvant radiation/chemoradiation as part of their routine care at the University of California, San Francisco (UCSF).

Conditions

  • Oral Cavity Squamous Cell Carcinoma

Interventions

DRUG

NisinZ® P

NisinZ® P is an ultrapure Nisin Z concentrate produced by fermentation using the bacterium Lactococcus lactis obtained from sauerkraut

PROCEDURE

Surgery (non-interventional, standard of care)

Surgical removal of tumor as part of standard of care treatment

Sponsors & Collaborators

Principal Investigators

  • Sue Yom, MD · University of California, San Francisco

  • Yvonne Kapila, MD · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2028-03-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097468 on ClinicalTrials.gov