head and neck carcinomas
Conditions
Interventions
Test group:Disitamab vedotin ,2.0 mg/kg, Q2W, iv, till PD or toxicity
Sponsors
Zhejiang Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged =18 years and =75 years; 2. ECOG score 0-2; 3.HER2 expression (IHC 1+, 2+, 3+) or HER2 amplification (ISH+ or NGS detection shows amplification); 4. Patients with metastatic or locally advanced head and neck tumors receiving chemotherapy progression or intolerance; 5. At least one measurable target lesion is present according to RECIST 1.1; 6. The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks before the drug, no use of leukocyte and platelet enhancing drugs) : 1) Blood routine: neutrophil (ANC) =1.5×10^9/L; Platelet count (PLT) =90×109/L; Hemoglobin (Hb) =90 g/L; 2) Blood biochemistry: total bilirubin (TBIL) = upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5×ULN; Alkaline phosphatase =2.5×ULN; Urea nitrogen (BUN) and creatinine (Cr) =1.5×ULN; 3) Heart color ultrasound: left ventricular ejection fraction (LVEF) =55%; 4) 12-lead ECG: Fridericia method corrected QT interval (QTcF) < 470 msec; 7. Have good compliance and willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. serious heart disease or discomfort, including but not limited to the following: a history of diagnosed heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-grade atrioventricular block (i.e. Mobitz II second-degree atrioventricular block or third-degree atrioventricular block); Angina pectoris requiring treatment with anti-angina drugs; Clinically significant valvular heart disease; ECG showed transmural myocardial infarction. Poor hypertension control (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) 2. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 3. Known allergic history of the drug components of this protocol; A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 4. Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or women of childbearing age who did not use effective contraception during the entire trial period and within 7 months after the last study; 5. Have a serious concomitant disease or other comorbidities that interfere with planned treatment, or any other condition in which the investigator considers the patient unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Progression free survival;Overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactMeiyu Fang
Zhejiang Tumor Hospital
Outcome results
None listed