A Prospective, Single-arm Clinical Study of Pabrolizumab in Combination With Cisplatin + 5-FU for the Neoadjuvant Treatment of Unresectable, Advanced Squamous Carcinoma of the Temporal Bone Single-arm Clinical Study

This is an interventional treatment trial for Temporal Bone Squamous Cell Carcinoma Read More

Inclusion Criteria:

1. Patients with advanced temporal bone carcinoma evaluated by an otolaryngologist as non-R0 resectable; CPS score > 20.
2. Patients who had undergone surgery, chemotherapy, radiotherapy, etc.
3. Patients with T4 advanced temporal bone cancer, Patients with nasopharyngeal carcinoma after radiotherapy

4. Hematology, biochemistry, and organ function:

   • Hemoglobin ≥100 g/L (can be maintained or exceeded by transfusion);
   • Neutrophil absolute count ≥2.0×109/L;
   • Platelet count ≥100×109/L;
   • Total bilirubin ≤1.5 times the upper limit of normal;
   • Alt and ASPARTate aminotransferase ≤2.5 times the upper limit of normal value;
   • Creatinine ≤1.25 times the upper limit of normal; The creatinine clearance rate was ≥60mL/min.
   • Women of childbearing age (18-49 years) must exclude pregnancy.

5. General admission criteria:

   • Obtain informed consent signed by the patient or his legal representative;
   • Good patient compliance;
   • Medications can be taken orally;
   • Male or female aged ≥18 years and < 75 years;
   • ECOG behavior status score 0-1, life expectancy > 12 weeks;
   • Both men and women of reproductive age agreed to use a reliable method of contraception before entering the trial, during the study, and up to 8 weeks after stopping the drug.

Exclusion Criteria:

Patients who had cancer other than temporal bone cancer during the five years before the initiation of treatment in this study were excluded from: fully cured with surgery and disease-free survival of at least 5 years; carcinoma in situ of the cervix; cured basal cell carcinoma; bladder epithelial neoplasms (including Ta and Tis);

• Known allergy to carboplatin, 5-FU, or any of the ingredients in this product;
• Confirmed or suspected active immune disease. The following conditions can be included: the absence of a specific external stimulus will not develop; Systemic treatment is not required.
• systemic use of steroid hormones (> 10mg/ day equivalent of prednisone) or immunosuppressants within 14 days before first administration. Aerosolized inhalation or topical administration of steroid steroids may be used in the absence of active immune disease.
• Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;
• Any unstable systemic disease, including: Active infection, uncontrolled hypertension, unstable angina, the onset of angina within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] Class II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease;
• Known human immunodeficiency virus (HIV) infection, active hepatitis B or C;
• Patients with mixed small cell lung cancer components;
• Pregnant or lactating women;
• A clear history of neurological or psychiatric disorders, including epilepsy or dementia;
• Conditions deemed unsuitable for inclusion by other researchers.