locally advanced head and neck
Conditions
Interventions
experimental group:Neoadjuvant Phase
Toripalimab: 240 mg, Day 1
Taxanes: Paclitaxel 175 mg/m^2, or Docetaxel 75 mg/m^2
Cisplatin: 75 mg/m^2, Day 1
Every 3 weeks is one treatment cycle, for 3 cycles to
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or older, any gender; 2. Participants with head and neck squamous cell carcinoma confirmed by pathology or cytology; 3. Unresectable locally advanced head and neck squamous cell carcinoma, stage III-IVb by TNM (according to the 9th edition of the UICC/AJCC cancer staging system); 4. No prior systemic anti-tumor therapy or local radical treatment for head and neck SCC; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. ECOG performance status score of 0-1; 7. Expected survival of at least 3 months; 8. Good major organ function, meeting the following criteria within 14 days before enrollment: (1) Hemoglobin >= 90 g/L (no blood transfusion in the past 14 days); (2) Neutrophil count > 1.5 x 10^9/L; (3) Platelet count >= 100 x 10^9/L; (4) Total bilirubin = 60 mL/min (Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Pathology diagnosis includes primary neuroendocrine-like tumors, mesenchymal tumors, and sarcomatoid differentiation head and neck tumors; 2. Currently participating in and receiving other research treatments; 3. Patients with meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active CNS metastases. Patients with supratentorial and/or cerebellar metastases (i.e., excluding midbrain, pons, or medulla) must have received local treatment and achieved stability at least 2 weeks before first use of the drug (imaging shows no new brain metastases or enlargement of existing brain metastases, and all neurologic symptoms are stable or returned to normal), and do not require corticosteroid treatment or are receiving prednisone =10 mg daily or an equivalent dose of other corticosteroids, can participate in the study; 4. History of other malignancies within 3 years before first use of the drug, except for the following: cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ; 5. Patients with active autoimmune disease or a history of autoimmune disease (such as ulcerative colitis or Crohn’s disease). Subjects who are stable and do not require systemic immunosuppressive treatment are allowed to enroll, such as those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); 6. Patients with congenital or acquired immunodeficiency, such as HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate;progression-free survival rate; recurrence-free survival rate; distant metastasis-free survival rate.; | — |
Countries
China
Contacts
Public ContactJin gao
Anhui Provincial Cancer Hospital
Outcome results
None listed