nasopharyngeal carcinoma
Conditions
Interventions
1:Toripalimab combined with IMRT (toripalimab 240mg every 3 weeks for 1 year or until confirming disease progression or unacceptable toxicity occurring)
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–70 years; 2.Pathologically confirmed WHO type II or III nasopharyngeal carcinoma; 3.Stage II~IVA according to AJCC/UICC 8th before induction chemotherapy; 4.Unsatisfactory response (SD/PD according to RECIST1.1) or detectable EBV DNA after induction chemotherapy; 5.ECOG performance status of 0 or 1; 6.Female of child bearing potential, a negative urine or serum pregnancy test result within 7 days before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 6 months after the last dose of Toripalimab; 7.No severe heart, lung, liver, kidney and other important organ dysfunction; 8.normal renal and hepatic function: ALT and AST = 60 mL/min; Adequate bone marrow function: absolute white blood cell count >= 4.0 x 10^9/L, neutrophil >= 2.0 x 10^9/L, hemoglobin >= 90 g/L, platelets >= 100 x 10^9/L); 9.Written informed consent with exact date obtained from the individual patients before certain proposed step.
Exclusion criteria
Exclusion criteria: 1.Allergy to monoclonal antibodies or any compound of study therapy; 2.Prior therapy with an anti-PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; 3.Following conditions within 4 weeks before enrollment: received traditional Chinese anti-tumor herbs, received any other anti-tumor drugs, underwent major surgery, had a history of serious trauma; 4.Have known autoimmune diseases, except the following two cases: patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone; patients with type 1 diabetes receiving stable insulin treatment regimen; 5.Received systemic immunostimulatory drugs (including but not limited to interferon or IL-2) within 4 weeks before enrollment or 5 half-lives of the drug; 6.Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except the following: inhalation or topical corticosteroids; 7.Previous bone marrow transplantation or organ transplantation; 8.Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, idiopathic pneumonia or other active pneumonia; 9.Received a live vaccine within 4 weeks of enrollment; 10.Active infection, including Hepatitis B (HBsAg +), Hepatitis C or Human Immunodeficiency Virus (HIV) infection (HIV antibody +); 11.Had poor treatment compliance because of mental or other basic diseases; 12.Pregnancy or breast feeding; 13.Uncontrolled cardiovascular disease: New York Heart Association (NYHA) class 3 or 4, myocardial infarction within a year, unstable angina, supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 14.Patients unable to be followed up regularly; 15.Accompanied by serious uncontrollable infection or medical diseases; 16.Inadequate organ function; 17.Laboratory examination: total bilirubin > 1.5 x upper limit of normal (ULN); AST and (or) ALT > 2.5 x ULN and ALP > 2.5 x ULN; 18.Conditions that may adversely affect pharmacokinetics: such as psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites and hydrothorax; 19.Suffered from an additional malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in-situ cervical.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Drug safety;Living quality; | — |
Countries
China
Contacts
Public ContactLyu Xing
Sun Yat-Sen University Cancer Center
Outcome results
None listed