Recruiting
Phase 1

Lidocaine

Sponsor:

Ryan Carey

Code:

NCT06747390

Conditions

Oropharyngeal Squamous Cell Carcinoma (OPSCCA)

Oropharyngeal Cancer

Human Papilloma Virus

Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine 1% Injectable Solution

Study Details

Brief summary:

Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.

Conditions

Oropharyngeal Squamous Cell Carcinoma (OPSCCA)

Oropharyngeal Cancer

Human Papilloma Virus

Squamous Cell Carcinoma

Study ID

NCT06747390

Start date

Apr 23, 2025

Status verified date

May, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients 18 years older or more.

Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.

Clinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).

Any clinical N stage disease (per AJCC 8th Ed).

Patients must be undergoing direct laryngoscopy +/- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.

Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.

Ability to understand and the willingness to provide written informed consent.

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Exclusion Criteria:

Prior external beam radiation therapy to the head and neck.

Prior chemotherapy for head and neck cancer.

Tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).

Presence of distant metastatic disease.

Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.

Known history of hypersensitivity to lidocaine or other amide local anesthetics.

Pregnant or breastfeeding.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Arm - No Injection

No injection at the time of direct laryngoscopy.

experimental: Lidocaine Injectible product

Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy.

Interventions

Lidocaine 1% Injectable Solution

1% lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg/kg body weight) into the primary tumor with the aim to distribute the lidocaine evenly into the tumor.

Primary outcome measure

  • Safety measured by occurrence of adverse events. [ Time Frame: 2 years ]
  • Pathological tumor response (pTR) in the primary tumor following surgical resection. [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Abramson Cancer Center at University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Ryan Carey

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • TransOral Robotic Surgery (TORS)
  • Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Cancer
  • Human Papilloma Virus
  • Squamous Cell Carcinoma
  • Lidocaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ryan Carey on 2026-05-12.