nasopharyngeal carcinoma
Conditions
Interventions
experimental group:GP+SHR-1210+SBRT
control group:GP
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years to 75 years; 2. Pathologically confirmed as nasopharyngeal carcinoma; 3. Primary metastatic nasopharyngeal carcinoma diagnosed by pathology or images; 4. No radiotherapy or chemotherapy was performed after firstly metastasis; 5. ECOG 0-1; 6. Life expectancy >=12 weeks; 7. Patients must have >= 1 measurable lesion (assessed by RECISTv1.1); 8. Patients should not receive blood transfusion or growth factor support within 14 days prior to blood sampling at screening. The indicator requirements are as follows: Absolute white blood cell count >= 4x 10^9/L; 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/1.73 m2; serum total bilirubin <= 1.5 x ULN (Patients with Gilbert syndrome can be enrolled if total bilirubin < 3 x ULN is present; AST and ALT <= 2.5 x ULN, and if the patient has liver metastases, this standard is AST and ALT <= 5 x ULN. 9. The patient has signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Only recurrent nasopharyngeal carcinoma; 2. Allergic to monoclonal antibodies, any camrelizumab components; 3. Patients currently have active autoimmune disease, or always exist autoimmune disease, or need to oral hormone or immune inhibitors to treat patients; 4. Receive treatment: anti-PD - 1 / PD - L1 ;The last anti-tumor therapy in patients within 1 month (including radiotherapy, chemotherapy and targeted therapy); Within one month of major surgery or suffer from serious injury 5. Not recovered to <= CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment 6. Combined the second primary tumor patient, except the skin basal cell carcinoma and cervical carcinoma in situ 7. Pregnant and lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2- year PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year OS;ORR;DCR;AE; | — |
Countries
China
Contacts
Public ContactNianyong Chen
West China Hospital, Sichuan University
Outcome results
None listed