head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:cadonilimab+ PF chemotherapy + local radiotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sex is not limited, age from 18 to 65 years old; 2) Pathologically confirmed untreated recurrent/metastatic head and neck squamous cell carcinoma, including oral cavity, oropharynx, larynx and hypopharynx; 2) Patients with recurrent/metastatic head and neck squamous cell carcinoma who are inoperable after MDT discussion 3) The patient has no economic conditions or has given up or is not suitable for monotherapy or combination therapy based on pembrolizumab; 4) Before treatment, there is at least one measurable lesion on CT or MRI;
Exclusion criteria
Exclusion criteria: 1) Previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies targeting ICOS, CD40, CD137, GITR , and Ox40 targets, etc.), immune cell therapy, etc. Any treatment targeting tumor immune mechanisms; 2) Patients who have received local radiotherapy in the past or = 6 months from the last radiotherapy; 3) Patients with active autoimmune disease or a history of autoimmune disease but possible relapse; Remarks: Patients with the following diseases are not excluded and can enter further screening: a. Controlled type 1 diabetes; b. Hypothyroidism (if controllable with hormone replacement therapy only); c. Controlled celiac disease; d. Skin disease not requiring systemic therapy (eg, vitiligo, psoriasis, alopecia); e. Any other disease that is not expected to recur in the absence of an external trigger; 4) Any active malignancy within = 2 years prior to enrollment, except specific cancers being studied in this trial and locally recurrent cancers that have been cured (eg: resected basal cell or squamous cell skin cancer, superficial bladder carcinoma, cervical carcinoma in situ or breast cancer, etc.); 5) Any disease requiring systemic corticosteroid therapy (a dose higher than 10 mg/day of prednisone or the equivalent dose of similar drugs) or other immunosuppressant therapy within = 14 days before enrollment; 6) There was uncontrolled diabetes = 14 days before enrollment or laboratory abnormalities of > grade 1 potassium, sodium or corrected calcium levels despite standard drug treatment or = grade 3 hypoalbuminemia; 7) History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.; 8) Severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibiotics, antibacterial or antiviral treatment occurred within 14 days before enrollment or the first administration of the study drug; 9) Known history of HIV infection; 10) Patients with untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA = 500 IU/mL or active hepatitis C virus (HCV) carriers should be excluded. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) and cured hepatitis C patients can be enrolled; 11) Any major surgery requiring general anesthesia was performed within =28 days before enrollment; 12) Previous allogeneic stem cell transplantation or organ transplantation; 13) Have any of the following cardiovascular risk factors: Cardiac chest pain, defined as moderate pain limiting instrumental activities of daily living, within = 28 days prior to enrollment Symptomatic pulmonary embolism within = 28 days prior to enrollment Acute myocardial infarction within = 6 months before enrollment New York Heart Association Class III or IV = 6 months prior to enrollment Grade = 2 ventricular arrhythmias occurred within = 6 months before enrollment or the first administration of the study drug History of cerebrovascular accident within 6 months before enrollment or first dose of study drug 14) Have a history of severe hypersensitivity to other monoclonal antibodies or any AK104 components; 15) History of allergic reaction to cisplatin, carboplatin and or fluorouracil; 16) = grade 2 peripheral nerv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactShichuan Zhang
Sichuan Cancer Hospital
Outcome results
None listed