A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC
Trial Parameters
Brief Summary
This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).
Eligibility Criteria
Inclusion Criteria: * Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma. * Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months. * Greater than or equal to 18 and less than 70 years of age at time of study entry. * ECOG performance status of 0 or 1. * Measurable disease as per RECIST 1.1. * Screening labs must meet the following criteria and must be obtained within 14 days prior to registration: 1. Adequate hepatic and renal function as demonstrated by 1. Serum creatinine \< 1.5 X ULN or CrCl \> 40mL/min (if using the Cockcroft-Gault formula below): * Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)） * Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85 2. AST/ALT ≤ 3 x ULN 3. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total