Nasopharyngeal carcinoma
Conditions
Interventions
Experimental Group:Vebecototota monoclonal antibody combined with putrilimab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients had to meet all of the following criteria: 1. Voluntarily sign the informed consent form, fully understand and informed the study and sign the informed consent (ICF); 2. Male or female, aged 18-75 years old (on the day of signing the informed consent form); 3. Histologically or cytologically confirmed nasopharyngeal carcinoma, metastatic nasopharyngeal carcinoma not suitable for local treatment or radical treatment (UICC-AJCC staging system 9th edition: stage IVA, IVB). Local treatment mainly refers to anti-tumor treatment measures, including surgery, radiofrequency ablation, radical radiotherapy, etc., excluding local radiotherapy to non-target lesions for symptom relief in patients with bone metastases. (4) For the first recurrence of nasopharyngeal and/or neck nasopharyngeal carcinoma after treatment, tissue or cytopathology of recurrent nasopharyngeal carcinoma should be obtained as far as possible, if pathology cannot be obtained, two or more imaging methods should be used to confirm the diagnosis. 5. Participants had not received previous systemic chemotherapy for recurrent/metastatic NPC. Previous use of PD-1/PD-L1 inhibitors in the definitive phase of treatment (e.g., induction, concurrent, or adjuvant therapy) was allowed, provided that treatment was completed at least 6 months before the first study dose. 6. Subjects were required to have at least one measurable lesion according to RECIST v1.1. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before first dose. 8. Expected survival >=12 weeks. 9. Have appropriate organ and hematopoietic function, according to the following laboratory tests: 1) neutrophil count (NEST #) >=1.5×10^9/L; Platelet count >=100×10^9/L; 2) hemoglobin >=90g/L; 3) serum creatinine <=1.5 times the upper limit of normal (ULN); 4)AST and ALT<=2.5 times ULN (<=5 times ULN for patients with liver metastasis); 5) serum total bilirubin (TBIL) <=1.5 times ULN; 6) international normalized ratio (INR) <=1.5 times ULN and activated partial thromboplastin time (APTT) <=1.5 times ULN (except patients receiving anticoagulant therapy). 10. A negative blood pregnancy test within 7 days before treatment in a female patient of reproductive potential; Women of reproductive age and men whose partner was a woman of reproductive age had to agree to use a highly effective method of contraception (e.g., oral contraceptives, intrauterine devices, libido control, or barrier contraception combined with spermicids) for 1 year from the time they gave their last dose of study medication.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria were not eligible for inclusion in the study: 1. Presence of peripheral neuropathy grade >=2 according to CTCAE 5.0; 2. Surgery or any other form of systemic or local antineoplastic therapy is anticipated to be required during the study trial; 3. Residual toxic reactions (except alopecia, fatigue, hypothyroidism, and radiation-related late sequelae) or clinically significant laboratory abnormalities higher than grade 1 (CTCAE v5.0) caused by previous antineoplastic therapy (including biological agents, targeted therapy, chemotherapy, or radiotherapy); 4. Patients with locally recurrent nasopharyngeal carcinoma and grade 3 or above nasopharyngeal necrosis; 5. History of severe cardiac insufficiency, stroke, or transient ischemic attack (TIA) within 6 months before enrollment. History of ventricular tachycardia or torsades de pointes. He had a clinically significant cardiac condition, including acute myocardial infarction, class III or IV congestive heart failure (New York Heart Association class), unstable angina, or arrhythmia requiring treatment within 6 months before the first study treatment. Note: Subjects with arrhythmia were eligible if they were receiving antiarrhythmic drug therapy and screening electrocardiogram (ECG) showed controlled rhythm. 6. Newly diagnosed or treated pulmonary embolism within 3 months before the first dose of study drug; 7. A known prior history of malignancy (except for those who have undergone successful definitive resection of skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or cervical cancer in situ), unless the subject has received potentially curative treatment and has not had disease recurrence within 5 years from the initiation of treatment. 8. Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) or hyperglycemia (fasting plasma glucose >8.9mmol/L or glycosylated hemoglobin (HbA1c) >8% in subjects with type 1 DM); 9. Subjects with previous grade >=3 immune-related AE (irAE), including but not limited to skin toxicity, diarrhea, enteritis, immune-related myocarditis, nephritis, immune-related liver damage, etc. 10. Known allergic reaction to any component or adjuvant of vibecutumumab, or known grade >=3 allergic reaction to other previous anti-EGFR drugs (including investigational drugs) or other monoclonal antibodies; 11. Known active hepatitis B or C. Active hepatitis B was defined as known HBsAg positivity and HBV DNA>=500 IU/mL. Active hepatitis C was defined as a known positive hepatitis C antibody and a known quantitative hepatitis C virus HCVRNA result greater than the lower limit of detection. The presence of other severe liver disease, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or nonalcoholic steatohepatitis (NASH); 12. Concurrent severe, uncontrolled infection or known human immunodeficiency virus (HIV) (HIV positive) infection, or a diagnosis of acquired immunodeficiency syndrome (AIDS); Or uncontrolled autoimmune disease; Or have received a previous allogeneic tissue/organ transplant, stem cell or bone marrow transplant, or a previous solid organ transplant; 13. Active bacterial, viral, fungal, rickettsial, or parasitic infections requiring systemic anti-infective treatment (unless treated and resolved before administration of the study drug); 14. Vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival period;Overall survival period; | — |
Countries
China
Contacts
Public ContactHuang Shuang
Zhejiang Cancer Hospital
Outcome results
None listed