nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Operation combined with Nimotuzumab and Camrelizumab treatment
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; 2.Locally recurrent nasopharyngeal carcinoma confirmed by pathology, according to TNM staging of recurrent nasopharyngeal carcinoma (AJCC, 8th edition, 2018), see appendix 1; 3.Indications for surgical treatment; 4.EGFR immunohistochemistry or FISH positive test was performed on tumor tissue samples; 5.ECOG:0-1; 6.Expected survival >=12 weeks; 7.The major organs are functioning normally, that is, they meet the following criteria: (1)Blood routine examination: 1)HGB>=70g/L; 2)ANC>=1.5x10^9/L; 3)PLT >=50x10^9/L; (2)Blood Biochemical examination: 1)ALB>=25g/L; 2)ALT?AST=60ml/min; 8.Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study;Negative serum or urine pregnancy test within 7 days prior to study enrolment and must be non-lactating;Men should agree to use contraception during the study period and within 6 months after the end of the study period; 9.Subjects volunteered to participate in this study, signed informed consent, and showed good compliance, and cooperated with follow up.
Exclusion criteria
Exclusion criteria: 1.The tumor breaks through the dural membrane of the skull base and severely involves the brain parenchyma, with distant metastases and significant complications, and the patient can not have general anesthesia; 2.Patients with recurrent or residual tumor after reirradiation; 3.The patient has any active or a history of autoimmune diseases (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, leucoderma, Asthma(that requiring medical intervention with bronchodilators); 4.The patient is taking immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other equal-efficacy hormone) and continued to be used within 2 weeks before enrollment; 5.Patients had received targeted combination immunotherapy with the same mechanism within the previous six months; 6.Patients with any severe and/or uncontrollable disease, including: patients with poor blood pressure control (systolic blood pressure >=160mmHg or diastolic blood pressure >= 100mmHg);Patients with myocardial ischemia or myocardial infarction of grade II or above, arrhythmia (including QT interval >=480ms) and Grade II cardiac insufficiency;active or uncontrolled severe infections;Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA>=104 copy number/mL or 2000IU/ mL) or hepatitis C (HCV-RNA is positive and HCV-RNA is above the detection lower limit); 7.Pregnant or lactating women; 8.Patients with other malignancies within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 9.People with a history of psychotropic drug abuse and cannot abstain from it or with mental disorders; 10.Patient have participated in clinical trials of other similar drugs within three months; 11.Patient has comorbidities, as determined by the investigator, that seriously endanger patient safety or affect patient completion of the study; 12.Patient who the investigator considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Quality score of life; | — |
Countries
China
Contacts
Public ContactYe Jing, Zhong Xiaojun
The First Affiliated Hospital of Nanchang University
Outcome results
None listed