Nasopharyngeal carcinoma
Conditions
Interventions
Test group:Cervical lymphadenectomy + Toripalimab
Control group:Cervical lymphadenectomy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-70 years. 2) Histologically and/or cytologically confirmed recurrent nasopharyngeal carcinoma non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III; 3) Primary nasopharyngeal and cervical lymph node lesions have been treated with radical dose radiotherapy; 4) Imaging findings of residual or recurrent cervical lymph nodes alone, clinical stage rT0N1-3M0, no distant metastasis; 5) KPS score = 70; 6) Patients have signed informed consent and are willing and able to comply with the study plan visit, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: 1) History of severe hypersensitivity reaction to other monoclonal antibodies or any component of PD-1 monoclonal antibodies or other monoclonal antibodies; 2) Inability to tolerate surgery, or surgery-related contraindications; 3) Known or suspected autoimmune diseases, including dementia and seizures; 4) Combined with nasopharyngeal recurrence or distant metastasis; 5) Combined with other malignant tumors; 6) Received high-dose glucocorticoid therapy within 4 weeks before enrollment.Patients with complications requiring long-term use of immunosuppressive drugs, or systemic or local use of corticosteroids with immunosuppressive doses; 7) Patients with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before screening; 8) Subjects with any active autoimmune diseases or history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood, without any intervention after adulthood can be included; patients with asthma requiring bronchiectasis for medical intervention can not be included); 9) HIV positive; HBsAg positive at the same time detected HBV DNA copy number positive (quantitative detection = 1000cps/ml); chronic hepatitis C blood screening positive (HCV antibody positive); 10) received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment; 11) women of childbearing age pregnancy test positive and lactating women; 12) Patients considered unsuitable for inclusion by other treating physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| failure-free survival, FFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;distant metastases-free survival, DMFS;local recurrence-free survival, LRFS;Safety index;Quality of life; | — |
Countries
China
Contacts
Public ContactYanfeng Chen
Sun Yat-sen University Cancer Center
Outcome results
None listed