nasopharyngeal carcinoma
Conditions
Interventions
control group:Tislelizumab, 200mg d1, q3w
Gemcitabine 1000mg/m2 d1 d8 q3w
Cisplatin, 80mg/m2 d1 q3w
Concurrent chemoradiotherapy, cisplatin 75 mg/m2, D1
Synchronize IMRT 70Gy/32f
treatment group:Tislelizumab, 200mg d1, q3w
Bevacizumab 7.5mg/kg D1
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in and sign the informed consent in person. 2. Aged 18-70, male or non-pregnant female. 3. Pathological diagnosis of nasopharyngeal non-keratosis (differentiated or undifferentiated, i.e., WHO type II or III). 4. The stage is ?-?a (8th AJCC/UICC stage) with N2=3cm or N3. 5. Initially treated locally advanced nasopharyngeal carcinoma patients who have not received any antitumor therapy before. 6. ECOG score 0-1. 7. Hemoglobin (HGB) =90 g/L, white blood cells (WBC) =4.0×109 /L, platelets (PLT) =100×109 /L. 8. Liver function: total bilirubin, AST, ALT=2.0× upper limit of normal value. 9. Renal function: creatinine clearance =60ml/min or creatinine =1.5× upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent and distant metastasis of nasopharyngeal carcinoma. 2. The pathological findings were keratinized squamous cell carcinoma (WHO type I). 3. Patients who have received radiotherapy or systemic chemotherapy. (4) Pregnant or lactating women, who are in the fertile period and do not take effective contraceptive measures. 5. Be HIV positive. 6. History of other malignancies (other than cured basal cell carcinoma or carcinoma in situ of the cervix). 7. Patients who have been treated with immunoregulatory point (CTLA-4, PD-1, PD-L1, etc.) inhibitors. 8. Patients with immunodeficiency diseases and a history of organ transplantation. 9. Patients treated with excessive doses of glucocorticoids, anticancer monoclonal antibodies, and other immunosuppressants within 4 weeks. 10. Patients with significantly low heart, liver, lung, kidney and bone marrow function. 11. Severe, uncontrolled medical disorders and infections. 12. Concurrent use of other investigational drugs or other clinical trials. 13. Refusal or inability to sign informed consent to participate in the trial. 14. People with other treatment contraindications. (15) Persons with personality or mental disorders, without or with limited capacity for civil conduct. 16. Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) =1000 cps/ml. 17. Patients who test positive for HCV antibodies may be enrolled in this study only if the PCR test for HCV RNA is negative. 18. Patients who are receiving or are highly likely to receive other chemotherapy, biotherapy, or immunotherapy have a history of severe hypersensitivity to other monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Survival rate without local recurrence; Survival rate without distant metastasis;safety; | — |
Countries
China
Contacts
Public ContactPeng Zhang
Sichuan Cancer Hospital
Outcome results
None listed