Head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:Toripalimab 240 mg + docetaxel 75 mg/m2 + cisplatin 75 mg/m2 IV q21d × 2 cyclesToripalimab 240 mg + docetaxel 75 mg/m2 + cisplatin 75 mg/m2 IV q21d × 2 cycles
control group:Toripalimab 240 mg IV q21d × 2 cycles
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed, newly diagnosed, non-metastatic, surgically resectable locally advanced head and neck squamous cell carcinoma, with no history of other malignancies; 2) Stage III p16-positive oropharyngeal cancer with primary tumor stage T4 and lymph node stage N0-N2; Stage III-IVA p16-negative oropharyngeal cancer; Stage III-IVA laryngeal, hypopharyngeal, or oral cavity cancer; 3) Performance status (ECOG) score of 0-1; 4) Age 18-70 years; 5) Pathologically confirmed locally advanced head and neck squamous cell carcinoma with PD-L1 CPS>= 1; 6) Laboratory test results within 7 days prior to enrollment meeting the following criteria: Hematology (no blood transfusion or hematopoietic growth factor treatment within 14 days before testing): Absolute neutrophil count (ANC) >= 2.0×10^9/L, platelets (PLT) >= 100×10^9/L; Liver function: total bilirubin <1.5× upper limit of normal (ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5× ULN; Renal function: serum creatinine <1.5× ULN; 7) Patient voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Prior head-and-neck cancer surgery or radiotherapy 2.Known hypersensitivity to toripalimab, docetaxel, cisplatin or their excipients 3.Pregnant or lactating women 4.Active or untreated hepatitis B (HBV-DNA >= 500 IU/mL), hepatitis C (HCV-RNA detectable), or HIV positive 5.Severe cardiac, pulmonary, hepatic or renal insufficiency precluding surgery 6.Other malignancies within 5 years (except adequately treated basal-cell carcinoma of skin or carcinoma in situ of cervix) 7.Organ transplant recipient on chronic immunosuppressive therapy 8.Active autoimmune disease requiring systemic immunosuppression within 2 years 9.Concurrent participation in another clinical trial 10.Psychiatric or social conditions preventing compliance with study procedures 11.Any condition that in the investigator’s opinion would place the patient at undue risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Event-Free Survival (EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Pathologic Complete Response Rate, pCR;Major pathological response rate, MPR; | — |
Countries
China
Contacts
Public ContactXuekui Liu
Sun Yat-sen University Cancer Center
Outcome results
None listed