Oropharyngeal Squamous Cell Carcinoma (OPSCCA)Phase 1856397NCT06747390
Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
A Phase 1 study testing Lidocaine 1% Injectable Solution in people with Oropharyngeal Squamous Cell Carcinoma (OPSCCA) and Oropharyngeal Cancer, run by Ryan Carey at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma (OPSCCA), Oropharyngeal Cancer, Human Papilloma Virus
- What is being tested?
- Lidocaine 1% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to 1 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- ---
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prannda Sharma, MS contact
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
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.
Read the detailed description
This is a phase I patient-blinded, randomized controlled trial evaluating intratumoral lidocaine injection prior to definitive surgery in HPV associated OPSCC. Patients with OPSCC undergoing direct laryngoscopy who are being considered for definitive TORS and selective neck dissection, will be eligible. Patients will be randomized and blinded to intratumoral injection of 1% lidocaine (intervention arm) or no injection (control arm) at the time of direct laryngoscopy. After administration of general anesthesia and biopsy, lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg/kg body weight) into the primary tumor.
Blood samples will be obtained prior to direct laryngoscopy/study intervention (pre-biopsy) and again after the intervention (post-biopsy). Following direct laryngoscopy/study intervention, patients will receive institutional standard of care treatment which may include primary surgery (TORS primary site resection, selective neck dissection, and any indicated adjuvant therapy) or primary radiation (with or without chemotherapy). For patients undergoing surgery, the pathological tumor response (pTR) rate (defined as the area with pathologic response/area pathologic response plus viable tumor) will be determined by the designated study pathologist using increments of 10% for the biopsy and surgery specimens. The scores will be grouped as pTR-0 (<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).
All enrolled patients will be assessed for safety measured by adverse events. If a patient does not ultimately receive primary surgery following their direct laryngoscopy/study intervention (based on surgical candidacy, patient preference, or other reasons), then they will not be counted as an evaluable subject, as the primary endpoint pTR requires a surgical specimen for evaluation. If a patient is determined to have a pathology other than HPV associated OPSCC after their direct laryngoscopy, then they will not be counted as an evaluable subject. The enrollment target will be 30 evaluable subjects.
Primary Objectives: Determine if intratumoral 1% lidocaine injection at the time of direct laryngoscopy prior to TORS and neck dissection for HPV associated OPSCC is safe and causes a major pathologic treatment effect.
Secondary Objectives: Determine if intratumoral 1% lidocaine injection at the time of direct laryngoscopy prior to TORS and neck dissection for HPV associated OPSCC improves the 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
- Being tested
- Lidocaine 1% Injectable Solution
- Keywords
- TransOral Robotic Surgery (TORS), Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancer, Human Papilloma Virus, Squamous Cell Carcinoma, Lidocaine
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% Injectable SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm - No Injection | No intervention | No injection at the time of direct laryngoscopy. |
| Lidocaine Injectible product | Experimental | Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy. Receives: Drug: Lidocaine 1% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by occurrence of adverse events.
Adverse events (AE) and Serious Adverse Events (SAE) will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The CTCAE v.5 utilizes a five point scale to report AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Measured: 2 years
Pathological tumor response (pTR) in the primary tumor following surgical resection.
The pathological tumor response (pTR) rate (defined as the area with pathologic response/area pathologic response plus viable tumor) will be determined by the designated study pathologist using increments of 10% for the biopsy and surgery specimens. The scores will be grouped as pTR-0 (<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).
Measured: 2 years
Secondary outcomes (4)
2-year locoregional control rates.
Locoregional control is defined as control at the primary site and in the neck.
Measured: 2 years
2-year progression-free survival.
Progression-free survival is defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse.
Measured: 2 years
2-year metastasis-free survival.
Metastasis-free survival is the length of time from the start of treatment for a disease until the patient remains alive without the development of distant metastatic disease.
Measured: 2 years
2-year overall survival.
Overall survival is defined as the length of time from the start of treatment for a disease that patients diagnosed with the disease are still alive.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start23 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal Squamous Cell Carcinoma (OPSCCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized and blinded to intratumoral injection of 1% lidocaine (intervention arm) or no injection (control arm) at the time of direct laryngoscopy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryan Carey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ryan Carey, Abramson Cancer Center at Penn Medicine
- Investigators
- Ryan Carey, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747390
- Sponsor's protocol ID
- UPCC12324
- Acronym
- 856397
- Status last verified
- May 2026
- First submitted
- 16 Dec 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miller ZA, Mueller A, Kim T, Jolivert JF, Ma RZ, Muthuswami S, Park A, McMahon DB, Nead KT, Carey RM, Lee RJ. Lidocaine induces apoptosis in head and neck squamous cell carcinoma through activation of bitter taste receptor T2R14. Cell Rep. 2023 Dec 26;42(12):113437. doi: 10.1016/j.celrep.2023.113437. Epub 2023 Nov 22.
PubMed 37995679Carey RM, McMahon DB, Miller ZA, Kim T, Rajasekaran K, Gopallawa I, Newman JG, Basu D, Nead KT, White EA, Lee RJ. T2R bitter taste receptors regulate apoptosis and may be associated with survival in head and neck squamous cell carcinoma. Mol Oncol. 2022 Apr;16(7):1474-1492. doi: 10.1002/1878-0261.13131. Epub 2021 Dec 14.
PubMed 34717036Badwe RA, Parmar V, Nair N, Joshi S, Hawaldar R, Pawar S, Kadayaprath G, Borthakur BB, Rao Thammineedi S, Pandya S, Balasubramanian S, Chitale PV, Neve R, Harris C, Srivastava A, Siddique S, Vanmali VJ, Dewade A, Gaikwad V, Gupta S. Effect of Peritumoral Infiltration of Local Anesthetic Before Surgery on Survival in Early Breast Cancer. J Clin Oncol. 2023 Jun 20;41(18):3318-3328. doi: 10.1200/JCO.22.01966. Epub 2023 Apr 6.
PubMed 37023374
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06747390
- Acronym / sponsor ID
- 856397 / UPCC12324
- Conditions
- Oropharyngeal Squamous Cell Carcinoma (OPSCCA), Oropharyngeal Cancer, Human Papilloma Virus, Squamous Cell Carcinoma
- Keywords
- TransOral Robotic Surgery (TORS), Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancer, Human Papilloma Virus, Squamous Cell Carcinoma, Lidocaine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ryan CareyUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I patient-blinded, randomized controlled trial evaluating intratumoral lidocaine injection prior to definitive surgery in HPV associated OPSCC. Patients with OPSCC undergoing direct laryngoscopy who are being considered for definitive TORS and selective neck dissection, will be eligible. Patients will be randomized and blinded to intratumoral injection of 1% lidocaine (intervention arm) or no injection (control arm) at the time of direct laryngoscopy. After administration of general anesthesia and biopsy, lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg/kg body weight) into the primary tumor.
Blood samples will be obtained prior to direct laryngoscopy/study intervention (pre-biopsy) and again after the intervention (post-biopsy). Following direct laryngoscopy/study intervention, patients will receive institutional standard of care treatment which may include primary surgery (TORS primary site resection, selective neck dissection, and any indicated adjuvant therapy) or primary radiation (with or without chemotherapy). For patients undergoing surgery, the pathological tumor response (pTR) rate (defined as the area with pathologic response/area pathologic response plus viable tumor) will be determined by the designated study pathologist using increments of 10% for the biopsy and surgery specimens. The scores will be grouped as pTR-0 (<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).
All enrolled patients will be assessed for safety measured by adverse events. If a patient does not ultimately receive primary surgery following their direct laryngoscopy/study intervention (based on surgical candidacy, patient preference, or other reasons), then they will not be counted as an evaluable subject, as the primary endpoint pTR requires a surgical specimen for evaluation. If a patient is determined to have a pathology other than HPV associated OPSCC after their direct laryngoscopy, then they will not be counted as an evaluable subject. The enrollment target will be 30 evaluable subjects.
Primary Objectives: Determine if intratumoral 1% lidocaine injection at the time of direct laryngoscopy prior to TORS and neck dissection for HPV associated OPSCC is safe and causes a major pathologic treatment effect.
Secondary Objectives: Determine if intratumoral 1% lidocaine injection at the time of direct laryngoscopy prior to TORS and neck dissection for HPV associated OPSCC improves the locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized and blinded to intratumoral injection of 1% lidocaine (intervention arm) or no injection (control arm) at the time of direct laryngoscopy.
| Arm | Type | Receives |
|---|---|---|
| Control Arm - No Injection | No intervention | –No injection at the time of direct laryngoscopy. |
| Lidocaine Injectible product | Experimental | Drug: Lidocaine 1% Injectable SolutionIntratumoral injection of 1% lidocaine at the time of direct laryngoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 1% Injectable Solution1% 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. | Drug | Lidocaine Injectible product |
Primary outcome
Safety measured by occurrence of adverse events.
Time frame: 2 years
Adverse events (AE) and Serious Adverse Events (SAE) will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The CTCAE v.5 utilizes a five point scale to report AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Pathological tumor response (pTR) in the primary tumor following surgical resection.
Time frame: 2 years
The pathological tumor response (pTR) rate (defined as the area with pathologic response/area pathologic response plus viable tumor) will be determined by the designated study pathologist using increments of 10% for the biopsy and surgery specimens. The scores will be grouped as pTR-0 (<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).
4 secondary outcomes
2-year locoregional control rates.
Time frame: 2 years
2-year progression-free survival.
Time frame: 2 years
2-year metastasis-free survival.
Time frame: 2 years
2-year overall survival.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 37995679Miller ZA, Mueller A, Kim T, Jolivert JF, Ma RZ, Muthuswami S, Park A, McMahon DB, Nead KT, Carey RM, Lee RJ. Lidocaine induces apoptosis in head and neck squamous cell carcinoma through activation of bitter taste receptor T2R14. Cell Rep. 2023 Dec 26;42(12):113437. doi: 10.1016/j.celrep.2023.113437. Epub 2023 Nov 22.
- Background: PubMed 34717036Carey RM, McMahon DB, Miller ZA, Kim T, Rajasekaran K, Gopallawa I, Newman JG, Basu D, Nead KT, White EA, Lee RJ. T2R bitter taste receptors regulate apoptosis and may be associated with survival in head and neck squamous cell carcinoma. Mol Oncol. 2022 Apr;16(7):1474-1492. doi: 10.1002/1878-0261.13131. Epub 2021 Dec 14.
- Background: PubMed 37023374Badwe RA, Parmar V, Nair N, Joshi S, Hawaldar R, Pawar S, Kadayaprath G, Borthakur BB, Rao Thammineedi S, Pandya S, Balasubramanian S, Chitale PV, Neve R, Harris C, Srivastava A, Siddique S, Vanmali VJ, Dewade A, Gaikwad V, Gupta S. Effect of Peritumoral Infiltration of Local Anesthetic Before Surgery on Survival in Early Breast Cancer. J Clin Oncol. 2023 Jun 20;41(18):3318-3328. doi: 10.1200/JCO.22.01966. Epub 2023 Apr 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prannda Sharma, MS contact
Ryan Carey, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine 1% Injectable Solution in people with Oropharyngeal Squamous Cell Carcinoma (OPSCCA) and Oropharyngeal Cancer, run by Ryan Carey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Carey, MD (2156622777, ryan.carey@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by occurrence of adverse events. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747390, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.