Advanced nasopharyngeal carcinoma
Conditions
Interventions
Control group:Tirellizumab combined with induction chemotherapy sequential concurrent chemoradiotherapy
Experimental group:Tirellizumab combined with induction chemotherapy and low dose radiotherapy were followed by concurrent chemoradiotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary and written informed consent to sign the study in person; 2.Age 18-70 years old, gender is not limited; 3.Pathological diagnosis of nasopharyngeal non-keratosis (differentiated or undifferentiated, i.e., WHO type II or III); 4. Clinical stage II to III (except T3N0-1M0) (AJCC 9th edition); 5.Newly treated nasopharyngeal carcinoma patients who had not previously received any antitumor therapy; 6.There were lesions that could be measured according to RECIST v1.1; 7.Karnofsky performance status (KPS) >=80; 8.Expected survival>=6 months; 9. Urine pregnancy test was negative (female), and contraceptive measures were taken during the trial period to 3 months after the trial ended; 10.Adequate hematopoietic function: WBC>=4×10^9/L, Hb>=100g/L, PLT>=100×10^9/L; 11. Liver function: ALAT/ASAT < 1.5 times of high normal value (ULN), bilirubin < 1.5×ULN; 12.Renal function: serum creatinine < 1.5×ULN; 13.According to the investigator's judgment, the patient was able to comply with the protocol;
Exclusion criteria
Exclusion criteria: 1. There is evidence of distant transfer; 2. The primary tumor or lymph node has been surgically treated (except biopsy); 3.Patients who have received radiotherapy or systemic chemotherapy; 4.Patients who had been treated with immunoregulatory point (CTLA-4, PD-1, PD-L1, etc.) inhibitors; 5.have had other malignant tumors (other than non-melanic skin cancer or cervical carcinoma in situ); 6. Subjects who have received other drug trials within the last 1 month; 7. Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period; 8.Have a history of severe allergies or idiosyncrasies; 9.A history of severe lung or heart disease or serious comorbidities, such as uncontrolled hypertension or heart failure; 10. Refusal or inability to sign the informed consent to participate in the trial; 11.Drug or alcohol addicts; 12.Persons with personality or mental disorders, without or with limited capacity for civil conduct; 13.Creatinine clearance; 14. Active systemic infection; 15.Concurrent chronic systemic immunotherapy or hormone therapy other than in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence-free survival;Distant Metastasis-Free Survival (DMFS);Safety Measure;Progression-free survival;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactFeng Mei
Sichuan Cancer Hospital
Outcome results
None listed