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

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

NCT ID: NCT05578170

Condition: Oral Cavity Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Pembrolizumab
Description: 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.
Arm group label: Pembro Neoadjuvant + SOC Adjuvant

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.

Criteria for eligibility:

Study pop:
Patients with stage III-IVA oral squamous cell carcinoma.(See Eligibility Criteria)

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Liuxiqiang

Address:
City: Guangzhou
Zip: 510515
Country: China

Status: Recruiting

Contact:
Last name: Liuxiqiang Liuxiqiang

Phone: 18688862086
Email: liuxiqiang@smu.edu.cn

Start date: June 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Nanfang Hospital, Southern Medical University
Agency class: Other

Source: Nanfang Hospital, Southern Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05578170