Nasopharyngeal carcinoma
Conditions
Interventions
Treatment Group:Four 3-week cycles of neoadjuvant treatment were administered. Tislelizumab 200 mg was given intravenously on Day 1
gemcitabine 1000 mg/m^2 was given intravenously on Days 1 and 8
and cisplatin 80 mg/m^2 was given intravenously on Day 1. Neoadjuvant treatment was followed by intensity-modulated radiotherapy: 70 Gy to the primary gross tumour volume, 66-68 Gy to the nodal gross
Sponsors
Jiangmen Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-70 years; 2. The pathological type of newly treated nasopharyngeal carcinoma patients is: nasopharyngeal non keratinizing carcinoma (differentiated or undifferentiated, i.e. WHO type II or III); 3. The clinical staging standard is AJCC 8th Edition IV A: (T4/N3); 4. ECOG score 0-1; 5. Expected survival time = 6 months; 6. Organ functions meet the following conditions: neutrophil count = 1.5 * 10 ^ 9/L, ALT and AST = 3 times the upper normal limit, bilirubin = 1.5 times the upper normal limit, and serum creatinine = 1.5 times the upper normal limit; 7. The patient agrees to join the clinical study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received treatment targeting PD-1 or PD-1; 2. Patients with active autoimmune diseases or with history of autoimmune diseases but possible recurrence; 3. There is any active malignant tumor within = 2 years before treatment, except for the specific cancer being studied in this trial and the locally recurrent cancer that has been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer cancer, cervical carcinoma in situ or breast cancer); 4. Any disease requiring systemic treatment with corticosteroids (prednisone with a dose higher than 10 mg/day or the equivalent dose of similar drugs) or other immunosuppressants and intravenous antibiotics within 14 days before treatment; 5. Have a history of uncontrolled diabetes; 6. History of the following diseases: interstitial lung disease, non infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, malignant hypertension, etc; 7. Patients with a history of severe allergy, such as laryngeal edema and anaphylactic shock; 8. It is prohibited to use any type of corticosteroid drugs 14 days before PD-1 use and during chemotherapy; 9. Antibiotics were injected intravenously 14 days before enrollment and during the treatment of new auxiliary period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate after neoadjuvant treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxic and side effects;objective response rate ;tumour response at 3 and 6 months after chemoradiotherapy; plasma EBV DNA clearance;disease-free survival;overall survival;treatment exposure; safety and tolerability; | — |
Countries
China
Contacts
Public ContactQinhua Zhang
Jiangmen Central Hospital
Outcome results
None listed