Locally Advanced Oral Squamous Cell Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Oral squamous cell carcinoma (OSCC) diagnosed as locally advanced (T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC staging criteria. 2. Their age ranged from 18 to 80 years;regardless of gender. 3. Absence of prior head and neck radiation therapy or chemotherapy. 4. Adequate blood function: white blood cell count (WBC) >=3.5×10^9/L, platelet count (PLT) >=75×10^9/L:Hemoglobin concentration (HGB) >=90g/L. 5. Adequate liver function: total bilirubin (TBIL) <= the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 times the upper limit of normal. 6. Adequate renal function:urinary white blood cells < 10, red blood cells < 10, cast count < 5 per high-power field, serum creatinine in the range of 186-351 mmol /L, and creatinine (CRE) <= the upper limit of normal. 7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI. 8. PS score <=2. 9. Signed informed consent form and voluntarily agreeing to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (for female participants); 2. Patients with a history of epilepsy or psychiatric disorders that were not well-controlled. 3. Patients with severe allergic diathesis or suspected or confirmed alcohol or drug addiction. 4. Patients who had taken antibiotics within 7 days before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| two-year progression-free survival rate;two-year overall survival rate; | — |
Countries
China
Contacts
Zhujiang Hospital of Southern Medical University