Nasopharyngeal carcinoma
Conditions
Interventions
Group 1:Chemotherapy plus immunotherapy, radiotherapy should be considered according to the condition.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Can provide written informed consent and understand and follow study requirements and evaluation schedule; 2. Aged 18-65 years at the date of signing the informed consent; 3. The patient was pathologically diagnosed with nasopharyngeal carcinoma by histological or cytological examination; 4. Metastatic nasopharyngeal carcinoma has been pathologically confirmed or radiographically diagnosed (stage IVB, AJCC 8th edition); 5. Did not receive any antitumor therapy after metastasis; 6. ECOG physical condition = 12 weeks; 8. The patient must have >= 1 evaluable lesion (assessed by RECISTV1.1); 9. Patients who were eligible for radiotherapy at enrollment or who were eligible for radiotherapy after chemotherapy as assessed by the investigator; 10. Adequate organ function, defined as achieving the following laboratory values within 7 days or less prior to enrollment (patients must not have received blood transfusion or growth factor support within 14 days prior to blood collection during screening): absolute neutrophil count >= 1.5 x 10^9/L; platelet >= 100 x 10^9/L; hemoglobin >= 90 g/L; international normalized ratio or prothrombin time = 60 mL/min/1.73m2; serum total bilirubin <= 1.5 x ULN (Gilbert syndrome patients with total bilirubin < 3 x ULN could be enrolled); AST and ALT <= 2.5 x ULN, if the patient has liver metastasis, the criterion is AST and ALT <= 5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Only patients with local recurrence of nasopharynx or neck region; 2. Patients who are allergic to any component of carrilizumab; 3. Patients with active autoimmune disease or a history of autoimmune disease but a possible recurrence (Note: Patients with the following diseases are not excluded and can be further screened: Controlled type 1 diabetes; Hypothyroidism (if controlled with hormone replacement therapy alone); Controlled celiac disease; Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia); Any other disease that is not expected to recur in the absence of an external trigger); 4. Any active malignancies within 2 or less years prior to inclusion, other than the specific cancers being studied in this study and locally recurrent cancers that have been cured (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast cancer); 5. Any condition requiring systemic corticosteroid therapy (dose higher than 10 mg/day of prednisone or equivalent dose of similar drugs) or other immunosuppressant treatment within = 1 day before enrollment, or >= 1 day after standard drug therapy; 7. History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.; 8. Severe chronic or active infections (including tuberculosis infections, etc.) that required systemic antibiotic, antimicrobial or antiviral therapy within 14 days prior to enrollment or prior to the first administration of the study drug; 9. Known history of HIV infection; 10. Untreated chronic hepatitis B patients or HBV carriers with chronic hepatitis B virus HBV-DNA >= 500 IU/mL or active hepatitis C virus (HCV) carriers should be excluded. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBVDNA = grade 2 occurred within 6 months or less before enrollment or the first administration of the study drug; (6) History of cerebrovascular accidents within 6 months prior to enrollment or the first administration of the study drug; 14. A history of severe hypersensitivity to other monoclonal antibodies; 15. A history of allergic reactions to cisplatin or gemcitabine; 16. Peripheral nerve disease >= grade 2, as defined by the National Cancer Institute Adverse Event Evaluation Criteria (NCI-CTCAE) V5.0 criteria; 17. Received live vaccine within 4 weeks or less prior to enrollment; 18. An underlying medical condition (including
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time, OS;Objective remission rate, ORR;Disease control rate, DCR;Safety and quality of life; | — |
Countries
China
Contacts
Public ContactNianyong Chen
West China Hospital of Sichuan University
Outcome results
None listed