Nasopharyngeal carcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age: >=18 years old, = 1.5 × 10^9/L; Ii Platelet count >=100 × 10^9/L; Iii. Hemoglobin>=9.0 g/dL. b) Kidney: i. The calculated value of serum creatinine= 50 mL/min* The Cockcroft Gault formula will be used to calculate CrCl (Cockcroft DW, 1976) CrCL (mL/min)={(140 age) x body weight (kg) x F}/(SCr (mg/dL) x 72), where F=1 for males and F=0.85 for females; SCR=serum creatinine. c) Liver: i. Total serum bilirubin (TBil) <= 1.5 × ULN; For subjects with liver metastasis or evidence of suspected Gilbert disease, TBil<= 3 x ULN Ii AST and ALT<= 2.5 × ULN; For subjects with liver metastasis, AST and ALT <= 5 × UL d) Coagulation function: The international standardized ratio and activated partial thromboplastin time are <=1.5 x ULN (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the time of screening). 8. Male participants and women of childbearing age must use contraception within 24 weeks from the start of the first study medication to the end of the last study medication.
Exclusion criteria
Exclusion criteria: 1.Individuals who are known to be intolerant to Tegio or allergic to its excipients. 2.There are multiple factors that affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction. 3.Suffering from other active malignant tumors within the two years prior to enrollment. Locally curable cancers (manifested as cured) are excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ. 4. Pregnant or lactating women (consider pregnancy testing for women of reproductive age; emphasize effective contraception during treatment). 5. When receiving recommended neoadjuvant chemotherapy or radiochemotherapy, immunotherapy was also administered. 6.Accompanied by other serious illnesses, it may bring significant risks or affect the compliance of the trial. For example, patients with active, known or suspected autoimmune diseases, or with a history of autoimmune diseases, HIV positive patients, inflammatory bowel disease, active pulmonary tuberculosis (TB), interstitial lung disease, allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, unstable heart diseases requiring treatment, kidney diseases, chronic hepatitis, diabetes with poor control (fasting blood glucose>1.5 × ULN), and mental diseases. 7. Previously received any anti PD-1, anti PD-L1, anti CTLA-4 antibodies, or any other antibody or drug therapy targeting T cell co stimulation or checkpoint pathways. 8. Known to have a history of abuse of psychotropic substances, alcoholism, or drug use. 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total survival time;Therapeutic toxicity;Compliance with treatment;Quality of life rating; | — |
Countries
china
Contacts
Public ContactSangang Wu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed