hypopharyngeal squamous cell carcinoma
Conditions
Interventions
experimental group:Neoadjuvant chemotherapy + surgery + radiotherapy
Control group:surgery+radiotherapy
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Obtain a signed written informed consent; 2. Tumor PD-L1 detection is positive (defined as cells expressing PD-L1 in the tumor >= 1%, that is (tumor cells + lymphocytes + macrophages + other cells in the tumor) / the number of all tumor cells * 100%, using Agilent Science and Technology (China) Co., Ltd. produces PD-L1 detection kit (immunohistochemical method for detection); 3. Aged >=18 and = 70 points (see appendix 1 for the KPS scoring standard); 8. Normal bone marrow reserve function and normal liver and kidney functions (the following laboratory tests should be performed within 7 days before the first administration to confirm that the patient's bone marrow, liver, and kidney functions meet the requirements for participating in the study): Hematology: Neutrophil count >= 2.0 x 10^9/L Platelet count >= 100 x 10^9/L Hemoglobin >= 10g/dl Liver function: Serum total bilirubin 120µmol/L, the creatinine clearance rate should be >= 60ml/min (the actual value or Cockcroft-Gault method is estimated as follows: Weight (kg) x (140-age) / K x serum creatinine Serum creatinine (mg/L): male K=7.2, female K=8.5 Serum creatinine (µmol/L): male K=0.814, female K=0.96) 9. Estimated survival time >= 6 months; 10. Good follow-up compliance; 11. Women of childbearing age (15-49 years old) must take a pregnancy test within 7 days before starting treatment and the result is negative; 12. Male and female patients with fertility must agree to use effective contraceptive measures to ensure that they do not become pregnant during the trial period and within 3 months after stopping the drug.
Exclusion criteria
Exclusion criteria: 1. Definite metastasis of hypopharyngeal carcinoma or other malignant tumors; 2. Previously received surgery for primary tumors or lymph nodes (except biopsy); 3. Have previously received radiotherapy for the primary tumor or lymph node; 4. Previously received anti-tumor biological targeted therapy; 5. Have previously applied chemotherapy or immunotherapy to the primary tumor; 6. Patients suffering from any malignant tumor in the past 5 years (cured skin basal cell carcinoma or cervical in situ Except for cancer); 7. Known grade 3-4 allergic reactions to any drugs in treatment; 8. Peripheral neuropathy> Grade 1; 9. Any unstable systemic disease (including active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure, which occurred within 12 months before enrollment Myocardial infarction, severe arrhythmia requiring medication, liver, kidney or metabolic disease); 10. Known human immunodeficiency virus (HIV) infection; 11. Chronic diseases that require immune preparations or hormone therapy; 12. Pregnant or lactating women; 13. Drug/alcohol abuse, or suffering from psychological or mental illnesses that may interfere with research compliance; 14. Patients with epilepsy who need medication (such as steroids or antiepileptic drugs); 15. Participated in other clinical trials in the past 30 days; 16. Situations considered by the researcher to be inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Laryngeal preservation rate;pathological Complete Response;overall survival;Local control rate; | — |
Countries
China
Contacts
Public ContactPin Dong
Shanghai General Hospital
Outcome results
None listed