recurrent head and neck squamous cell carcinoma
Conditions
Interventions
Test group:Kadonilimab+salvage resection+Kadonilimab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years; 2) Pathologically diagnosed with local recurrent head and neck squamous cell carcinoma (including oral, oropharyngeal, laryngeal, and hypopharyngeal cancer), with a time of = 6 months from completion of initial treatment (surgery and/or radiation therapy) to diagnosis of local recurrence; Residual disease, and = 2 weeks after completion of initial treatment); 3) Excitable diseases determined by surgeons; 4) Capable of providing archived biopsy or tissue removal; 5) Eastern Oncology Collaborative Group (ECOG) PS <2; 6) No distant metastasis; 7) with tolerable hematopoietic function (Absolute neutrophil count =1.8 × 109 / L platelets =100 × 109/L, Hemoglobin =9g/dL), liver function (Bilirubin =1.5 ULN ALT and AST =2.5 ULN), renal function (Serum creatinine = 1.5 ULN), and coagulation function (INR=1.5 ULN); 8) No serious organic heart disease or arrhythmia; 9) Not pregnant during treatment and 3 months after treatment. 10) With written informed consents.
Exclusion criteria
Exclusion criteria: 1) Patients with distant metastasis; 2) Patients with a history of Allergy, congenital immunodeficiency, human immunodeficiency virus (HIV) infection, autoimmune diseases, or other diseases that require long-term systemic use of hormone drugs or immunosuppressive therapy; 3) Active infections, including active hepatitis B or C infections (HBV DNA, HCV RNA exceeding the upper limit); 4) Previously received organ transplantation; 5) Serious cardiovascular, respiratory, or immune system major diseases; 6) Pregnant or lactating women; 7) Patients participating in other clinical studies at the same time; 8) with a history of mental illness (such as schizophrenia, mania, anxiety disorder, depression, phobia, etc.) or diagnosed with mental illness at the time of clinical trial enrollment; With communication barriers or inability to respond normally due to reasons such as blurred consciousness, aphasia, and intellectual disability; 9) Having other malignant tumor diseases; 10) Other factors that are not suitable for inclusion or are unable to complete the study.
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 ContactFei Chen
West China Hospital, Sichuan University
Outcome results
None listed