Oral Cavity Squamous Cell CarcinomaPROBESNCT05578170
Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
An observational study of Oral Cavity Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage III-IVA oral squamous cell carcinoma.(See Eligibility Criteria)
Who may be able to join
- Age 18-70
- Male and female
- Patients histologically or cytologically difined as oral cavity squamous cell carcinoma
- According to the American Joint Committee on Cancer ( AJCC 8th Edition ) , patients with resectable stage III-IVA OCSCC
- ECOG performance status ≤ 1
- Patients with normal bone marrow and organ function as defined below:
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- Blood routine examination:
- Absolute neutrophil count ≥ 1.5×109/L;
- Platelets ≥ 100.0×109/L;
- Hemoglobin ≥ 9.0 g/dL.
- Liver function:
- Totle bilirubin ≤ 2.0×ULN(Upper Limit Of Normal);
- Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase
- 2.5×ULN;
- Albumin ≥ 2.8g/dL.
- Renal function:
- (1)Creatinine clearance rate > 60.0ml/min.
- Coagulation function:
- (1)International Normalized Ratio ≤ 1.5；Activated Partial Thromboplastin Time ≤ 1.5×ULN
- Prior to and during study, and lasting 120 days for the final utilization of pembrolizumab, patients approve of contraception
- Patients voluntarily agree to participate in the study and sign the informed consent form
Who cannot join
- Prior treatment for OCSCC (sugery, immunotherapy, radiotherapy, chemotherapy)
- Patients with metastatic OCSCC with an unknown primary tumor site
- Patients with infectious disease: AIDS, hepatitis, active tuberculosis
- Received a live vaccine within 30 days prior to the first dose of pembrolizumab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin ( BCG ), typhoid vaccine, or attenuated flu vaccine
- 5.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
- Currently receiving any other investigational agents
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- Has a history of allergic reactions attributed to compounds of similar chemical of biologic composition to pembrolizumab or other agents used in the study
- Patients with ongoing or active infectoin requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements
- Has a or more active autoimmune disease
- Has a history( non-infectious ) pneumonitis that required steroids or current pneumonitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liuxiqiang
Guangzhou, Guangdong, 510515
Liuxiqiang Liuxiqiang, 18688862086, liuxiqiang@smu.edu.cn
About this study
The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. The primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (pTR-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections > 50%). The secondary endpoints are 1-year disease-free survival (DFS), 1-year overall survival (OS) and the incidence of adverse events, compared with historical data. In addition, we will check the relevant immune indicators, such as PD-L1 and CPS scores.
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Being tested
- Pembrolizumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Participants receive 200 mg pembrolizumab as a neoadjuvant by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pembro Neoadjuvant + SOC Adjuvant | Not described Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathologic tumor response-2（pTR-2）
The proportion of participants with a pathologic tumor response-2（pTR-2）as assessed by the Central Pathologist at the time of definitive surgery. pTR-2 is defined as the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections > 50%
Measured: Up to 30 days post-sugery
Secondary outcomes (3)
Disease-free Survival (DFS)
DFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause
Measured: Up to 1 year
Overall Survival (OS)
OS is the time from surgery to death due to any cause.
Measured: Up to 1 year
Adverse Events (AEs)
Participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy
Measured: From time of first dose of study treatment until the end of follow-up (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu xiqiang，MD, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578170
- Sponsor's protocol ID
- NFEC-2022-082
- Acronym
- PROBES
- Status last verified
- Feb 2023
- First submitted
- 8 Oct 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05578170
- Acronym / sponsor ID
- PROBES / NFEC-2022-082
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. The primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (pTR-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections > 50%). The secondary endpoints are 1-year disease-free survival (DFS), 1-year overall survival (OS) and the incidence of adverse events, compared with historical data. In addition, we will check the relevant immune indicators, such as PD-L1 and CPS scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembro Neoadjuvant + SOC Adjuvant | – | Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage III-IVA oral squamous cell carcinoma.(See Eligibility Criteria)
Key inclusion criteria (21 listed)
- Age 18-70
- Male and female
- Patients histologically or cytologically difined as oral cavity squamous cell carcinoma
- According to the American Joint Committee on Cancer ( AJCC 8th Edition ) , patients with resectable stage III-IVA OCSCC
- ECOG performance status ≤ 1
Key exclusion criteria (10 listed)
- Prior treatment for OCSCC (sugery, immunotherapy, radiotherapy, chemotherapy)
- Patients with metastatic OCSCC with an unknown primary tumor site
- Patients with infectious disease: AIDS, hepatitis, active tuberculosis
- Received a live vaccine within 30 days prior to the first dose of pembrolizumab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin ( BCG ), typhoid vaccine, or attenuated flu vaccine
- 5.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
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 |
|---|---|---|
| PembrolizumabParticipants receive 200 mg pembrolizumab as a neoadjuvant by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles before surgery. | Drug | Pembro Neoadjuvant + SOC Adjuvant |
Primary outcome
Rate of pathologic tumor response-2（pTR-2）
Time frame: Up to 30 days post-sugery
The proportion of participants with a pathologic tumor response-2（pTR-2）as assessed by the Central Pathologist at the time of definitive surgery. pTR-2 is defined as the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections > 50%
3 secondary outcomes
Disease-free Survival (DFS)
Time frame: Up to 1 year
Overall Survival (OS)
Time frame: Up to 1 year
Adverse Events (AEs)
Time frame: From time of first dose of study treatment until the end of follow-up (up to 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 21 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathologic tumor response-2（pTR-2） (time frame: Up to 30 days post-sugery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023.