Clinical trial NCT05578170: Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
Official title: Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cavity Squamous Cell Carcinoma
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage III-IVA oral squamous cell carcinoma.(See Eligibility Criteria)

Brief 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. 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.


Eligibility criteria: 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:

1. Absolute neutrophil count ≥ 1.5×109/L;
2. Platelets ≥ 100.0×109/L;
3. Hemoglobin ≥ 9.0 g/dL.

Liver function:

1. Totle bilirubin ≤ 2.0×ULN(Upper Limit Of Normal);
2. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase

   * 2.5×ULN;
3. 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

Primary outcomes:
measure: Rate of pathologic tumor response-2（pTR-2）
timeFrame: Up to 30 days post-sugery
Secondary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: Up to 1 year
measure: Overall Survival (OS)
timeFrame: Up to 1 year
measure: Adverse Events (AEs)
timeFrame: From time of first dose of study treatment until the end of follow-up (up to 1 year)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Liuxiqiang
state: Guangdong
Study officials:
References: