Nasopharyngeal carcinoma
Conditions
Interventions
Case series:Tislelizumab combined with induction chemotherapy and maintenance chemotherapy
Sponsors
Daping Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Both male and female, aged >= 18 years old and = 4000 copies/ml. 4. According to RECIST 1.1 criteria, there is at least one measurable lesion. 5. ECOG score is = 1.5 x10^9/L; platelets >= 1.0 x 10^11/L; hemoglobin >= 90g/L; serum albumin >= 30g/L; total bile ducts Red pigment60ml/min; activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 x ULN (screenable for use of stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and INR within the expected therapeutic range of anticoagulants). The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergy to gemcitabine, cisplatin and tislelizumab. 2. Associated with other organs, tissue metastasis. 3. Received any anti-tumor therapy in the past. 4. Concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study. 5. Subjects who need to be given corticosteroids or immunodeficiency inhibitors for systemic treatment within 2 weeks before the first use of the study protocol. 6. Patients who have received oral or intravenous antibiotics within 2 weeks before starting treatment; patients who receive prophylactic antibiotics (such as to prevent urinary tract infections or prevent exacerbation of chronic obstructive pulmonary disease) can be enrolled. 7. Serious infection (CTCAE>2 grade) occurred within 4 weeks before the first use of the study protocol, such as severe pneumonia, bacteremia, and infectious complications requiring hospitalization. 8. Those who have been vaccinated with anti-tumor vaccines or who have received live vaccines within 4 weeks before the first administration of the study protocol. 9. Active autoimmune disease, history of autoimmune disease. 10. Have a history of immunodeficiency, including HIV positive test, or other acquired and congenital immunodeficiency diseases. 11. Active hepatitis B [chronic or acute; defined as positive hepatitis B surface antigen (HBsAg) test results and HBV DNA copy number>1000cps/ml during the screening period] or hepatitis C patients. 12. Patients with active pulmonary tuberculosis. 13. Significant cardiovascular disease, such as New York College of Cardiology-defined cardiac disease (grade II or higher), myocardial infarction, unstable arrhythmia, unstable angina pectoris within 3 months prior to treatment; known to suffer from Coronary artery disease, congestive heart failure not meeting the above criteria, or patients with left ventricular ejection fraction 90%), such as adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix. 18. Female patients who are pregnant or breastfeeding and refuse or cannot contraception. 19. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors, Situations that may affect subject safety or the collection of trial data. 20. Other conditions deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 9-week complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year failure-free survival;3-year distant failure-free survival;3-year locoregional failure-free survival;1-year EBV DNA clearance;3-year overall survival;Incidence rate of adverse event; | — |
Countries
China
Contacts
Public ContactShuai Wang
Amy Medical Center Of PLA
Outcome results
None listed