Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Rate of pathologic tumor response-2（pTR-2）
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Pembro Neoadjuvant + SOC Adjuvant
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Rate of pathologic tumor response-2（pTR-2）
时间窗: 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%
次要结局
- Overall Survival (OS)(Up to 1 year)
- Disease-free Survival (DFS)(Up to 1 year)
- Adverse Events (AEs)(From time of first dose of study treatment until the end of follow-up (up to 1 year))
研究者
Liu xiqiang，MD
Doctor of Medicine，Chief Physician
Nanfang Hospital, Southern Medical University