Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Zimberelimab combined with cisplatin, 5-FU
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical studies; 2. Aged 18-70 years; 3. Patients with head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, but not nasopharyngeal cancer) confirmed by histopathology or cytology at stage ?-?B or with local recurrence without distant metastasis were graded according to the UICC/AJCC TNM staging system (8th edition); 4. The physical status score of the Eastern Oncology Consortium (ECOG) was 0 to 1; 5. According to RECIST 1.1, at least one measurable lesion is suitable to be used as a target lesion (measurable lesion is defined as non-lymph node lesion with the longest single diameter >=10mm, or lymph node lesion with a short diameter >=15mm, with clear and repeatable boundaries); 6. The patient agrees to provide adequate tumor tissue samples for detection of PD-L1 expression; 7. Those who have no family planning within 1 year.
Exclusion criteria
Exclusion criteria: 1. Patients who have received other antitumor therapies (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) or participated in clinical studies of other drugs within 4 weeks prior to the start of study therapy; 2. Patients requiring systemic therapy with corticosteroids (>10mg/ day equivalent of prednisone) or other immunosuppressive agents within 14 days prior to study drug administration; 3. Patients who had bleeding events with a severe grade of 3 or above in CTCAEv5.0 within 4 weeks prior to screening and were judged to be at high risk of bleeding; Or International standardized ratio (INR) or plasma prothrombin time (PT) > 1.5xULN; Patients with abnormal coagulation function and bleeding tendency; Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogities; 4. Clinical symptoms or diseases of heart that are not well controlled, such as NYHA2 or above heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; Clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; QTc>450ms (male); QTc>470ms(female); 5. Patients with severe complications, such as active gastrointestinal massive bleeding, perforation, jaundice, gastrointestinal obstruction, and active severe clinical infections; 6. Abnormal liver and kidney function: serum total bilirubin > 1.5xULN; Aspartate aminotransferase (AST) > 2.5xULN; Alanine aminotransferase (ALT) > 2.5xULN; Serum creatinine > 1.5xULN or creatinine clearance (CrCl) 70 years, PS score >2, hearing impairment, renal insufficiency (creatinine clearance < 50ml/min), or grade 1 neuropathy; 11. Any conditions that the investigator considers to be at risk to patients who may receive the study drug treatment, or that would interfere with the evaluation of the study drug or with the safety of the subjects or the interpretation of the study results; 12. Conditions that other researchers considered unmanageable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response rate;major pathological response rate;2- and 5-year disease-free survival rates;2- and 5-year overall survival;safety; | — |
Countries
China
Contacts
Public ContactRen Xiaoyong
Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed