nasopharyngeal carcinoma
Conditions
Interventions
Case series:Sintilimab combined with gemcitabine plus cisplatin and primary radiotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient has signed an informed consent form; 2. Aged 18 years to 65 years; 3. Pathologically confirmed as nasopharyngeal carcinoma; 4. nasopharyngeal carcinoma with distant metastasis at first diagnosis (IVB, AJCC version 8 staging); 5. patients must be able to provide fresh or archived tumor tissue (FFPE tissue blocks or approximately 10 [=6] freshly harvested, unstained FFPE slides) and their pathology reports. Archived tumor tissue must be collected within 2 years prior to study screening. If tumor tissue is not adequately archived, fresh tumor biopsy specimens must be taken at baseline; 6. ECOG 0-1; 7. Patients must have = 1 measurable lesion (assessed by RECISTv1.1); 8. In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial; 9. Life expectancy =12 weeks; 10. Patients should not receive blood transfusion or growth factor support within 14 days prior to blood sampling at screening. The indicator requirements are as follows: Absolute white blood cell count = 4x 10^9/L; absolute neutrophil count = 1.5 x 10^9/L; platelet = 100 x 10^9/L; hemoglobin = 90 g/L; international normalized ratio or prothrombin time = 1.5 x normal range Upper limit (ULN); activated partial thromboplastin time = 1.5 x ULN; serum creatinine = 1.5 x ULN or estimated glomerular filtration rate = 60 mL/min/1.73 m2; serum total bilirubin = 1.5 x ULN (Patients with Gilbert syndrome can be enrolled if total bilirubin < 3 x ULN is present; AST and ALT = 2.5 x ULN, and if the patient has liver metastases, this standard is AST and ALT = 5 x ULN.
Exclusion criteria
Exclusion criteria: 1. has received treatment targeting PD-1 or PD-L1; 2. Patients with active autoimmune diseases or who have a history of autoimmune diseases but may relapse; Remarks: Patients with the following diseases are not excluded and can be further screened: (1) controlled type 1 diabetes; (2) hypothyroidism (if only hormone replacement therapy can be used); (3) Controlled celiac disease; (4) Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, hair loss); (5) Any other disease that is expected to not recur without external triggers; 3. Any active malignancy within = 2 years prior to randomization, except for the specific cancer being studied in this trial and the locally recurring cancer that has been cured (eg resected basal cells or squamous cell skin cancer, superficial bladder cancer, Cervical carcinoma in situ or breast cancer); 4. Any condition requiring systemic treatment with corticosteroids (dose higher than 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within = 14 days prior to randomization; 5. There is uncontrolled diabetes in =14 days before randomization or laboratory test abnormalities of >1 grade potassium, sodium or corrected calcium levels or =3 grade hypoalbuminemia despite standard drug therapy; 6. History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.; 7. Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibiotics, antibacterial or antiviral therapy before randomization or within 14 days prior to the first dose of study drug; 8. A history of HIV infection is known; 9. Untreated chronic hepatitis B patients or chronic hepatitis B virus (HBV) DNA = 500 IU/mL HBV carriers or active hepatitis C virus carriers (HCV) should be excluded. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) and cured hepatitis C patients can be enrolled; 10. Have any major surgery requiring general anesthesia = 28 days before randomization; 11. Previous allogeneic stem cell transplantation or organ transplantation; 12. There are any cardiovascular risk factors: Cardiac chest pain occurs within = 28 days before randomization and is defined as moderate pain that limits the instrumental activity of daily life; Symptomatic pulmonary embolism occurred = 28 days before randomization; Acute myocardial infarction occurred = 6 months before randomization; Meet New York Heart Association III or IV before = 6 months before randomization; A =2 grade ventricular arrhythmia occurred within =6 months prior to the first dose of randomized or study drug; A history of cerebrovascular accidents before randomization or within 6 months prior to the first dose of study drug; 13. A history of severe hypersensitivity to other monoclonal antibodies; 14. a history of allergic reactions to cisplatin or gemcitabine; 15. =2 peripheral neuropathy, as defined by the NCI CTCAE v5.0 standard; 16. Received live vaccine within = 4 weeks before randomization; 17. It is not conducive to the study drug administration or the interpretation of drug toxicity or AE or the underlying medical condition (including laboratory abnormalities) or the abuse or dependence of alcohol or drugs that leads to inadequate or potentially impaired research implementation; 18. Parti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);progression free survival (PFS);adverse events; | — |
Countries
China
Contacts
Public ContactNianyong Chen
West China Hospital, Sichuan University
Outcome results
None listed