recurrent or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histopathological diagnosis of head and neck squamous cell carcinoma (HNCSC), originating from the oral cavity, oropharynx, hypopharynx, or larynx; 2.confirmed HNCSC patients with recurrence or metastasis.; 3.all patients receiving first-line treatment; 4.age 18-75 years; 5.ECOG score 0-1; 6.adequate hematological, renal, and hepatic function; (1)Blood tests: Neutrophils >=1.5×10^9/L, Platelets >=100×10^9/L, Hemoglobin >=90g/L. (2)Liver function: ALT and AST =50ml/min (for carboplatin-treated subjects). 7.Inability to achieve initial cure with local treatment for R/M-HNCSC; 8.At least one measurable lesion per RECIST 1.1 criteria; 9.Complete clinical documentation; 10.Survival exceeding 3 months.
Exclusion criteria
Exclusion criteria: 1.Nasopharyngeal carcinoma, thyroid carcinoma, and skin cancer; 2.patients with R/M-HNSCC who could initially be cured through localized treatment; 3.patients with locally advanced HNSCC experiencing disease progression within 6 months after completing comprehensive treatment; 4.patients who have previously received systemic chemotherapy or ICIs; 5.patients known to have severe allergic reactions to medications such as albumin-bound paclitaxel, cetuximab, carboplatin, or tegafur; 6.patients with central nervous system metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;overall survival;safety; | — |
Countries
China
Contacts
Peking University Shenzhen Hospital