unresectable and advanced temporal bone squamous cell carcinoma
Conditions
Interventions
Group 1:The patient received four cycles of pabolizumab (200 mg intravenous drip, 21 day cycle) combined with 5-FU (500 mg/m2 intravenous drip) + cisplatin (80 mg/m2 intravenous drip, 21 day cycle).
Sponsors
Sun Yat Sen Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Evaluated by an otolaryngologist as an unresectable R0 advanced temporal bone cancer patient; 2. The CPS score of PD1 is greater than 10 points; 3. Patients who have undergone surgery, chemotherapy, radiation therapy, etc. for recurrence; 4. Patients with T4 advanced temporal bone cancer; 5. Patients with nasopharyngeal carcinoma after radiotherapy.
Exclusion criteria
Exclusion criteria: 1. Patients with cancers other than temporal bone cancer within five years before the start of treatment in this study, except for the following conditions: Completely cured by surgery and have a disease-free survival period of at least 5 years, cervical cancer in situ, cured Basal cell carcinoma, bladder epithelial tumor [including Ta and Tis]; 2. Known hypersensitivity to cisplatin, 5-FU or any ingredients in this product; 3. Diagnosed or suspected active immune disease. The following conditions can be included in the group: no disease will occur in the absence of a clear external stimulus; no systemic treatment is required; 4. Systemic use of steroid hormones (> 10 mg/day prednisone equivalent) or immunosuppressants within 14 days before the first medication of the study. In the absence of active immune disease, aerosol inhalation or topical steroids can be used; 5. Previously suffered from interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence; 6. Any unstable systemic disease, including: active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (>= New York Heart Association [NYHA] Grade II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; 7. Known human immunodeficiency virus (HIV) infection, active hepatitis B or C; 8. Pregnant or lactating women; 9. There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia; 10. Other researchers think that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resectable rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival (DFS);Perioperative complications; | — |
Countries
China
Contacts
Public ContactChen Suijun
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed