Locally advanced nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Induction chemotherapy plus trilaciclib
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old; (2) Pathological diagnosis of nasopharyngeal carcinoma; (3) Locally advanced nasopharyngeal carcinoma with AJCC stage III to IVb; (4) ECOG score 0-1; (5) No contraindications to chemotherapy and radiotherapy; (6) The functional level of major organs meets the following criteria: 1) The standard of blood routine examination should meet: WBC=3.0×10^9/L, ANC=2.0×10^9/L, PLT=100×10^9/L, HGB=90 G /L (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct within 30 days) 2) Biochemical examination should meet the following criteria: TBIL=1.50 ×ULN, ALT, AST=2.5 ×ULN, albumin = 30 g/L, creatinine = 15mg/L or creatinine clearance =60 mL/min (Cockcroft-Gault formula); 3) Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) =1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use; 4) myocardial enzyme spectra were within the normal range; (7) All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must use reliable contraception from the signing of the informed consent until 3 months after the last dose; For male subjects whose partner is a woman of childbearing age, a reliable contraceptive method should be used from the time of signing the informed consent until 3 months after the last dosing.
Exclusion criteria
Exclusion criteria: (1) Patients who had received chemoradiotherapy in the last 6 months were excluded; (2) Previous or co-existing uncured malignant tumors, except cured basal cell carcinoma of skin, squamous epithelial carcinoma of skin, carcinoma in situ after radical resection; (3) Uncontrolled cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =470 ms); According to NYHA criteria, ?-? cardiac insufficiency, or left ventricular ejection fraction (LVEF) 480msec during screening; For patients with implanted ventricular pacemakers, QTcF > 500msec; (6) Previously received hematopoietic stem cell or bone marrow transplantation; (7) Allergic to the investigational drug or its ingredients; (8) If the subject has undergone major surgery, the resulting toxic effects and/or complications must be adequately recovered; (9) within 4 weeks prior to the first use of the investigational drug (for subjects who have entered the follow-up period, it is calculated as the last use of the investigational drug or device) or are participating in another clinical study; (10) Pregnant or lactating women; (11) In the investigator's judgment, the subject has other factors that may have led to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that may have affected the subject's safety or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence (percent of patients) of severe neutropenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade 3 or 4 thrombocytopenia;The incidence of grade 3 or 4 anemia;The incidence of febrile neutropenia;The utilization rate of granulocyte colony-stimulating factor (G-CSF);Platelet transfusion rate;Red blood cell transfusion rate;Erythropoietin (ESA) utilization rate;Recombinant human interleukin-11 and/or thrombopoietin (TPO) utilization rate; | — |
Countries
China
Contacts
Public ContactQiao qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed