head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:Irinotecan liposomes + cisplatin +5-Fu
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with locally advanced head and neck squamous cell carcinoma confirmed by histopathology (stage II/III/IV, M0), including but not limited to oral cancer, oropharyngeal cancer, larynx cancer, hypopharyngeal cancer, nasopharyngeal cancer, etc.; (2) Subjects voluntarily participate in the study and sign an informed consent form (ICF); (3) 18-75 years old (including upper and lower limits); (4) At least one evaluable lesion at baseline according to RECIST 1.1 criteria; The area must not have received prior radiation (5) ECOG score 0~1; Expected survival =3 months (6) no serious dysfunction of heart, lung, liver, kidney and other vital organs; Normal liver and kidney function: AST and ALT 4.0×10^9/L, neutrophils >1.0×10^9/L, hemoglobin >90 g/L, platelets >100×10^9/L;
Exclusion criteria
Exclusion criteria: (1) Allergic to irinotecan or liposome drugs; (2) Use of a strong inducer of CYP3A4 within 2 weeks prior to first administration, or use of a strong inhibitor of CYP3A4 or a strong inhibitor of UGT1A1 within 1 week; (3) Active hepatitis B (HbsAg or HBcAb positive with HBV DNA=2000IU/mL), active hepatitis C (HCV antibody positive with HCVRNA higher than the lower limit of the detection value in the research center); If patients had normal liver function and were taking antiviral drugs, the investigators determined whether they were eligible for enrollment. (4) HIV-positive patients; (5) Active bacterial infection, fungal infection, viral infection, or interstitial pneumonia requiring systemic treatment within 1 week prior to initial drug administration; (6) Anti-tumor therapy such as chemotherapy, small molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosine) within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to the first administration of the study drug; (7) Those who had undergone major surgery within 3 months prior to the first dosing, or planned to undergo major surgery during the study period; (8) Severe embolic events, such as cerebrovascular accidents (including transient ischemic attacks) and pulmonary embolism, occurred within 6 months prior to screening; (9) Active malignancies within 2 years prior to the first study drug administration, other than squamous cell carcinoma of the head and neck studied in this trial and any locally curable tumors that have undergone radical treatment (e.g. resected basal cell or squamous cell skin cancer, superficial cardiac dysfunction, including cysts, cervical or breast carcinoma in situ); (10) Severe cardiovascular disease in the 6 months prior to enrollment, including but not limited to the following: ? Acute myocardial infarction, unstable angina pectoris, coronary angioplasty or stenting, deep vein thrombosis, stroke; ? New York Heart Association Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50%; ? According to the investigator's assessment, abnormal electrocardiogram (ECG) at the time of screening was clinically significant; (11) Pregnant or lactating women; (12) Have any serious and/or uncontrollable medical conditions that the investigator determines may affect the patient's participation in the study (including, but not limited to, uncontrolled diabetes, kidney disease requiring dialysis, serious liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.); (13) Situations in which participation is deemed inappropriate by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD; | — |
Countries
China
Contacts
Public ContactXie Ke
Sichuan Provincial People's Hospital
Outcome results
None listed