Recurrent head and neck squamous cell carcinoma
Conditions
Interventions
Test group:Kadonilimab+Ivonescimab+salvage resection
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18-80 years old; 2) Gender is not limited; 3) histologically or cytologically confirmed locally recurrent head and neck squamous cell carcinoma (including primary sites, such as oral, oropharyngeal, laryngeal or hypopharyngeal cancer), from completion of initial treatment (surgery and/or radiation therapy, including/excluding platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local recurrence >=6 months; or persistent disease, > = 2 weeks after completion of initial therapy (surgery and/or radiation therapy, including/excluding platinum chemotherapy or cetuximab targeted therapy); 4) Resectable disease as determined by the surgeon and team; 5) Able to provide archival biopsy or excision of tissue; 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 3.5×10^9/L, absolute number of lymphocytes >= 0.8×10^9/L, absolute neutrophil count >= 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >=90g/L); 9) good liver function (bilirubin level = 60 ml/min (Cockcroft-Gault formula), urine routine check urine protein less than 2+, or 24-hour urine protein quantification<1g); 11) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN, if the study participant is receiving anticoagulant therapy, as long as the PT is within the intended range of anticoagulant use; 12) No serious organic heart disease and arrhythmia; 13) Women of childbearing age (15~49 years old) must undergo pregnancy study within 7 days before starting treatment and the result is negative; Male and female patients of childbearing potential must agree to use effective contraception to ensure that they do not become pregnant during the study and within 3 months after stopping treatment; 14) Obtain the "informed consent" signed voluntarily by the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with distant metastasis of head and neck squamous cell carcinoma after initial treatment; 2) Patients with allergies, congenital immunodeficiency, human immunodeficiency virus (HIV)-positive, history of autoimmune diseases, or other diseases requiring long-term systemic use of hormone drugs or immunosuppressive therapy; 3) Active infection, including active type B (HBV DNA exceeding the upper limit of normal); 4) Previous organ transplantation; 5) Serious cardiovascular, respiratory, or immune system diseases; Including urinary tract obstruction, positive cardiac stress test, myocardial infarction, arrhythmia, obstructive or restrictive lung disease, or other diseases that, in the opinion of the investigator, may increase the risk of the study participant; 6) Pregnant or lactating females; 7) the patient does not agree to use effective contraception during the treatment period and for the subsequent 3 months; 8) Patients who participate in other clinical studies at the same time; 9) Patients who are critically ill and unable to complete the investigation; 10) Patients with a history of mental illness (such as: schizophrenia, mania, anxiety, depression, phobias, etc.) or patients or spouses who have been diagnosed with mental illness at the time of enrollment in clinical trials; 11) Patients or their spouses who are unable to respond normally due to confusion, aphasia, intellectual disability and other reasons; 12) Have other malignant tumor diseases; 13) There are other factors that, in the opinion of the investigator, are not suitable for inclusion or affect the participation or completion of the study participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival;Pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactLei liu
West China Hospital, Sichuan University
Outcome results
None listed