Head and neck cancer
Conditions
Interventions
Trial group:Paclitaxel Oral Solution + Tislelizumab + Cetuximab
Paclitaxel Oral Solution: The recommended dose is 200 mg/m2 administered orally once weekly, on Day 1 and Day 8 of each cycle. Each trea
15 cycles are administered postoperatively.
Cetuximab: The initial dose is 400 mg/m2, followed by a subsequent maintenance dose of 500 mg/m2 administered intravenously every 2 weeks. Each treatment cy
Sponsors
Shanghai Ninth People's Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Ages 60 to 90 years inclusive, regardless of gender; 2. Patients diagnosed with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) by histopathological or cytological examination; diagnosed as stage II to IVa according to the AJCC Cancer Staging Manual (8th Edition), and planned for surgical resection or with an estimated lesion burden that can be potentially reduced to enable surgery; 3. ECOG score 0-3; 4. Normal bone marrow reserve function: neutrophil count (NEUT) >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L, hemoglobin (Hb) >=80 g/L; 5. Meeting one of the following platinum-intolerance criteria: (1) Age >70 years; (2)ECOG PS score >2; (3) Renal dysfunction (creatinine clearance grade 1; (6)Patients who refuse platinum-based chemotherapy or refuse peripherally inserted central venous catheter (PICC) placement. 6. Voluntarily participate in this study, sign the informed consent form, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous anti-tumor drug therapy for head and neck squamous cell carcinoma, including but not limited to chemotherapy, targeted therapy, immunotherapy, etc.; 2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 3. History of life-threatening hypersensitivity or known allergy to any component of the investigational drug; 4. Participation in other drug or medical device clinical trials and receipt of investigational drugs or devices within 4 weeks prior to the first dose; 5. Major surgery within 28 days prior to the first dose, or patients planning to undergo major surgery during the study period; 6. Use of immunosuppressive drugs within 14 days prior to the first dose of tislelizumab, excluding nasal sprays, inhaled corticosteroids, or physiological doses of systemic steroids (i.e., not exceeding 10 mg/day of prednisone or equivalent doses of other corticosteroids); 7. History of other malignancies within the past 5 years (except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, papillary thyroid cancer, and ductal carcinoma in situ); 8. Active tuberculosis or other serious infectious diseases, including but not limited to: bacteremia, severe infectious pneumonia, or other serious infections requiring systemic treatment; 9. Active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); except for vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA = 500 IU/mL), hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay), or co-infection with hepatitis B and C; 11. Based on the investigator's judgment, the subject is considered unsuitable for oral administration of the investigational drug at the time of participation: (1) Clinically significant or uncontrolled congenital or acquired gastrointestinal diseases; (2) Subjects diagnosed with conditions that may affect the administration, entry into the digestive tract, or absorption of the investigational drug, including intestinal obstruction and inflammatory bowel disease (Crohn's disease and ulcerative colitis); 12. Poorly controlled or clinically significant cardiac symptoms or diseases, such as: (1)Myocardial infarction within the past 6 months; (2) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 13. Other circumstances deemed by the investigator as inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Objective Response;Event Free Survival;2-year Overall Survival;5-year Overall Survival; | — |
Countries
China
Contacts
Public ContactZhu Qi
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Outcome results
None listed