nasopharyngeal carcinoma
Conditions
Interventions
Test group:Tislelizumab combined with TPF regimen induction therapy and sequential concurrent chemoradiotherapy and adjuvant therapy
Sponsors
The People's Hospital of Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed WHO Type II/III nasopharyngeal carcinoma (nonkeratinizing nasopharyngeal carcinoma). 2. Male or female, aged from 18 to 70 years. 3. Stage ?-?a (8th AJCC/UICC ), excluding T3N0M0. 4. Have not received anti-tumor therapy of nasopharyngeal carcinoma. 5. At least one evaluable target lesion (recist1.1). 6. ECOG score 0-1. 7. Expected survival expectancy of no less than 6 months. 8. Hematopoietic function: absolute value of neutrophil =1.5×109/L, platelet = 90×109/L, hemoglobin = 90g/L 9. Liver function: In non-hepatitis B patients, total bilirubin, ALT and AST were lower than 1.5×ULN (upper limit of normal).Patients with hepatitis B should take effective antiviral drugs with HBV-DNA copy <2000 IU/ml and ALT<2×ULN 10. Renal function: creatinine < 1.5×ULN and creatinine clearance =50ml/min 11. Electrocardiogram and chest imaging showed no clinical abnormality, no obvious contraindications to chemotherapy. 12. Signed a written informed consent form (ICF) voluntarily.
Exclusion criteria
Exclusion criteria: 1.subjects with pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx. 2. Participated in clinical trial with an investigational drug or used an investigational device within 4 weeks prior to initial dosing 3. Subjects who had necrotic lesions and were assessed by the investigator to be prone to major bleeding 4. Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures 5. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are excluded. 6. Patients who had received myelosuppressive toxic symptomatic therapy within 7 days prior to enrollment 7. Patients treated with excessive doses of corticosteroids and other immunosuppressants within 4 weeks prior to the first dose 8. Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator. 9. Patients with a history of immunodeficiency, HIV-positive antibody testing, known active syphilis infection, and active hepatitis C 10. history of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis or active pulmonary tuberculosis (TB) 11. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 13. Patients who have had any major surgical procedures =28 days prior to the first administration of the study drug must have fully recovered from the toxicity and/or complications caused by the intervention prior to the first administration of the study drug 14. known history of serious hypersensitivity to other monoclonal antibodies 15. Peripheral neuropathy = grade 2 16. Patients with a history of clinically significant prolonged QT interval (male >450ms, female >470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), symptomatic coronary heart disease requiring medication 17. Patients with end-diastolic fluid dark area =10mm in ultrasound 18. Patients with mental disabilities/inability to obtain informed consent 19. Patients with drug or chronic alcohol abuse 20. The investigators determined that patients were not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Overall survival, OS;Local regional recurrence free survival;Distant metastasis-free survival, DMFS; | — |
Countries
China
Contacts
Public ContactShenhong Qu
The People's Hospital of Guangxi Zhuang Autonomous Region
Outcome results
None listed