Nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Vibecotamab combined with Pucotenlimab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age at diagnosis: 18 to 75 years old; 2.The patient is diagnosed with non-keratinizing carcinoma (WHO standard) of nasopharynx, which is the initial treatment; 3.Diagnosed as locally advanced nasopharyngeal carcinoma (T4N1 and T1-4N2-3) according to the 9th edition clinical staging system of the American Joint Committee on Cancer and the International Union Against Cancer (AJCC/UICC). All subjects must undergo the following examinations before the first treatment to determine the clinical stage: complete medical history, physical examination, blood routine and biochemical routine tests, plasma EBV DNA titer and serological tests, nasopharyngoscopy, head and neck magnetic resonance imaging (MRI), chest radiography or chest computed tomography (CT), abdominal ultrasound, and bone imaging. In addition, 18F-fluorodeoxyglucose positron emission tomography/CT (PET/CT) can be used as an alternative to the last three imaging examinations mentioned above; 4.ECOG score: 0-1; 5.Bone marrow function is normal: white blood cell count > 4×10^9/L, hemoglobin concentration > 90g/L, platelet count > 100×10^9/L; 6.Liver and kidney function are normal: total bilirubin = 1.5 times the upper limit of normal; 7.aspartate aminotransferase and/or alanine aminotransferase = 2.5 times the upper limit of normal; 8.alkaline phosphatase = 2.5 times the upper limit of normal; 9.creatinine clearance rate = 60 mL/min; 10.The results of thyroid function tests, amylase and lipase tests, pituitary function tests, inflammatory infection indicators, myocardial enzyme tests, troponin tests, and electrocardiogram (ECG) examinations are normal. For patients aged over 50 with a history of smoking, normal pulmonary function test results are required. For patients with abnormal ECG or a history of cardiovascular disease (but not meeting the exclusion criteria), additional myocardial function tests and cardiac color Doppler ultrasound examinations are necessary, and normal results are required; 11.The subjects must sign the informed consent form and must be willing and able to comply with the study protocol, including visits, treatment regimens, laboratory tests, and other requirements; 12.Female subjects who are capable of bearing children and male subjects who have fertile sexual partners must agree to use reliable contraceptive measures (such as condoms, contraceptive pills taken regularly as prescribed by a doctor) from screening to within 1 year after treatment. :;
Exclusion criteria
Exclusion criteria: 1. Hepatitis B surface antigen is positive and hepatitis B virus quantification is >1×10^3 copies/mL, or anti-hepatitis C virus antibody is positive; 2. Positive anti-HIV antibody or diagnosed with Acquired Immune Deficiency Syndrome (AIDS); 3. Active tuberculosis: Regardless of whether treatment has been administered, patients with a history of active tuberculosis within the past year should be excluded; 4. Except for patients who have been confirmed to have previously received regular anti-tuberculosis treatment, patients with a history of active tuberculosis for more than 1 year should be excluded; 5. Active, known, or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilation). Excluding type I diabetes, hypothyroidism requiring hormone replacement therapy, and dermatoses not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia); 6. Clinicians need to conduct necessary medical history inquiry, physical examination, tests, and examinations for the aforementioned diseases before enrollment to exclude them; 7. Thymic epithelial tumors (TETs), including thymoma, thymic carcinoma, and thymic neuroendocrine tumors (NETTs). Having suffered from interstitial lung disease or pneumonia within the past year, requiring oral or intravenous steroid treatment; 8. Having used vancomycin within the past month; 9. Subjects receiving chronic systemic glucocorticoid therapy (at a dose equal to or exceeding 10 mg prednisone per day) or any other form of immunosuppressive therapy are eligible; 10. Subjects receiving inhaled or topical corticosteroids are also eligible; 11. Uncontrolled heart diseases, such as: (1) heart failure, NYHA class >=2; (2) unstable angina; (3) history of myocardial infarction within the past year; (4) supraventricular or ventricular arrhythmias requiring treatment or intervention; 12. Women who are pregnant or breastfeeding (pregnancy tests should be considered for sexually active women of childbearing age); 13. Except for fully treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer, having previously or currently suffered from other malignant tumors; 14. Known hypersensitivity to any component or excipient of Vibecotamab (monohydrate citric acid, disodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80), or known hypersensitivity to other previous anti-EGFR drugs (including investigational research drugs) or other monoclonal antibodies with a severity level of >=3;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate, CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS ;Progression Free Survival, PFS;Overall survival, OS ; | — |
Countries
China
Contacts
Public ContactTing Jin
Zhejiang Cancer Hospital
Outcome results
None listed