Hypopharyngeal squamous cell carcinoma
Conditions
Interventions
experimental group:PD-1 monoclonal antibody combined with docetaxel and loboplatin undergoing surgery and postoperative radiotherapy
control group:Surgery and postoperative radiotherapy
Sponsors
Shanghai First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have obtained the signed written informed consent; 2. Patients with positive tumor PD-1 (defined as tumor cells expressing PD-1 >= 1%); 3. Patients aged >= 18 years and = 70 points (see Appendix 1 for KPS scoring standard); 7. Normal bone marrow reserve function and normal liver and kidney functions (the following laboratory tests were conducted 7 days before the first administration to confirm that the bone marrow, liver and kidney functions of the patients met the requirements of 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 120 µ mol / L, creatinine clearance 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 (µ mol / L): male k = 0.814, female k = 0.96 8. Patients with expected survival >= 6 months; 9. Follow up patients with good compliance; 10. Pregnant women of childbearing age (15-49 years old) must have a negative pregnancy test within 7 days before treatment; 11. The male and female patients with fertility shall agree to use effective contraceptive measures to ensure that they are not pregnant during the trial period and within 3 months after discontinuation.
Exclusion criteria
Exclusion criteria: 1. Patients with clear distant metastasis or other malignant tumors of hypopharyngeal carcinoma; 2. Patients who have previously received surgery for primary tumor or lymph node (except biopsy); 3. Patients who have previously received radiotherapy for primary tumors or lymph nodes; 4. Patients who have received anti-tumor biological target therapy before; 5. Patients who have previously used chemotherapy or immunotherapy for primary tumors; 6. Patients with any malignant tumor in the past 5 years (cured skin basal cell carcinoma or cervix in situ ancer excluded); 7. Patients with a known level 3-4 allergic reaction to any drug in the treatment; 8. Patients with peripheral neuropathy > grade 1; 9. Patients with any unstable systemic disease (including active infection, uncontrolled high blood pressure, unstable angina, angina pectoris that starts to attack in the last three months, congestive heart failure, myocardial infarction that occurs in the first 12 months before enrollment, serious arrhythmia requiring drug treatment, liver, kidney or metabolic diseases); 10. Patients with known human immunodeficiency virus (HIV) infection; 11. Patients with chronic diseases requiring immunotherapy or hormone therapy; 12. Pregnant or lactating women; 13. Patients with drug / alcohol abuse or mental or other diseases that may interfere with study compliance; 14. Patients with epilepsy requiring drug treatment (such as steroids or antiepileptic drugs); 15. Patients who have participated in other clinical trials in the past 30 days; 16. The researchers think it is not suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| partical response; | — |
Countries
China
Contacts
Public ContactPin Dong
Shanghai First People's Hospital
Outcome results
None listed