Recurrent/metastatic squamous cell carcinoma of the head and neck
Conditions
Interventions
experimental group:Iparomlimab and Tuvonralimab, 5mg/kg,q3w
Sponsors
Pingxiang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed as squamous cell carcinoma of the head and neck, and previously received first-line systemic treatment; 2. Age >= 18 years old; 3. ECOG PS score of 0-1; 4. Expected survival time >= 12 weeks; 5. At least one measurable lesion according to iRECIST criteria; 6. Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days before enrollment (no correction treatment with any blood components, cell growth factors, albumin or other drugs within 14 days before obtaining the laboratory tests), as follows: (1) Blood routine: absolute neutrophil count (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 75×10^9/L; hemoglobin content (HGB) >= 9.0 g/dL; (2) Liver function: serum total bilirubin (TBIL) = 28g/L; (3) Renal function: serum creatinine (Cr) = 50mL/min (Cockcroft-Gault formula); urine routine test shows urine protein = 2+ at baseline, 24-hour urine collection is required and 24-hour urine protein quantification < 1g; (4) Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5×ULN; 7. For female subjects of childbearing age, a urine or serum pregnancy test must be negative within 3 days before the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; 8. If there is a risk of pregnancy, all subjects (regardless of gender) agree to use a contraceptive method with a failure rate of less than 1% per year throughout the treatment period until 60 days after the last administration of the study drug; 9. Understand and voluntarily sign the written informed consent form, and the investigator determines that they can comply with the visit, treatment plan, laboratory tests and other research-related procedures specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who have received anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody treatment, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways in first-line therapy; 2. Patients with untreated active brain metastases or leptomeningeal metastases; 3. Patients with active autoimmune diseases or a history of autoimmune diseases that may recur; Note: Patients with the following diseases are not excluded and can proceed to further screening: (1) Controlled type 1 diabetes; (2) Stable hypothyroidism treated with hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease); (3) Controlled celiac disease; (4) Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia); (5) Any other disease that is not expected to recur without external triggers. 4. Patients with any active malignant tumor within grade 1 despite standard drug treatment or grade >= 3 hypoproteinemia within = 500 IU/mL or active HCV carriers should be excluded. Note: Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA = 2 ventricular arrhythmia within <= 6 months before enrollment or the first administration of the study drug; (6) History of cerebrovascular accident within <= 6 months before enrollment or the first administration of the study drug. 14. Patients with a history of intestinal obstruction within 6 months before enrollment (including incomplete in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival of the disease;overall survival;Disease control rate;Duration of relief;safety; | — |
Countries
China
Contacts
Public ContactFan Cai
Pingxiang People's Hospital
Outcome results
None listed