Temporal Bone Carcinoma
Conditions
Interventions
Control group:Conventional preoperative chemotherapy 2 course and postoperative radiotherapy
Experimental group:Conventional treatment + Pabolizumab was treated with 2 courses before and 6 courses after surgery
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Inclusion criteria: Patients with advanced T3/T4 temporal bone cancer had CPS scores greater than 10. The details include: ? obtain the informed consent signed by the patient or his legal representative; ? Patient compliance is good; ? can be taken orally; ? Male or female =18 years old and < 75 years old; ? ECOG behavior status score 0-1, life expectancy is greater than 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. 2) Hematological, biochemical and organ function requirements: ? Hemoglobin =100 g/L (can be maintained or exceeded by blood transfusion); ? Absolute neutrophil count =2.0×109/L; ? Platelet count =100×109/L; ? Total bilirubin =1.5 times the upper limit of normal value; ? Glutamic pyruvic transaminase and glutamic oxalacetic transaminase =2.5 times the upper limit of normal value; ? Creatinine =1.25 times the upper limit of normal value; Creatinine clearance =60mL/min;
Exclusion criteria
Exclusion criteria: ?Patients with cancers other than temporal bone cancer in the five years prior to the start of treatment in this study, except for cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors [including Ta and Tis], who were completely cured by surgery and had at least 5 years of disease-free survival; ? Known to be allergic to carboplatin, 5-FU or pabolizumab; ? Any unstable systemic disease, including: Active infection, uncontrolled hypertension, unstable angina, onset of angina within the last 3 months, congestive heart failure (= NYHA Level II), myocardial infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease; ?Known human immunodeficiency virus (HIV) infection, active hepatitis B or C; ? Pregnant or lactating women; ? Have a clear history of neurological or mental disorders, including epilepsy or dementia; ? Situations considered unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overal survival,OS;Progression-Free-Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of adverse events; | — |
Countries
China
Contacts
Public ContactChen Suijun
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed