Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma

Recruitment & Eligibility

Inclusion Criteria

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:

Blood routine examination:

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

Exclusion Criteria

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
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

Study & Design

Arm && Interventions

Group	Intervention	Description
Pembro Neoadjuvant + SOC Adjuvant	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Rate of pathologic tumor response-2（pTR-2）	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%

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 1 year	OS is the time from surgery to death due to any cause.
Disease-free Survival (DFS)	Up to 1 year	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
Adverse Events (AEs)	From time of first dose of study treatment until the end of follow-up (up to 1 year)	Participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy

Recruitment & Eligibility