Squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental Group:Initial treatment stage
Cadonilimab: 10mg/Kg (body weight), d1, intravenous drip
Albumin-paclitaxel: 260mg/m^2, d1, intravenous drip
Cisplatin: 25mg/m 2, d1-3 or carboplatin: AUC=5,
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old (including the threshold), gender not limited; 2.ECOG score: 0-1 point; 3. Patients with recurrent or metastatic squamous cell carcinoma of the head and neck confirmed by histopathology or cytology; 4. According to RECIST v1.1, there is at least one measurable tumor lesion. It was confirmed by CT or MRI examination during the baseline screening period that the long diameter of the lesion was >=10mm (the short diameter of the lymph node lesion was >=15mm), and according to RECIST v1.1, this lesion was suitable for repeated and accurate measurement. 5. The patient has never received PD-1 or PD-L1 treatment before; 6. Laboratory test results during the screening period indicated that the subjects had good organ function (no blood transfusion and no cell growth factor support treatment within 2 weeks before screening), including: a) Blood routine: neutrophils (ANC) >= 1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Hemoglobin (Hb) >=90 g/L; b) Blood biochemistry: Total bilirubin (TBIL) =50mL/min. For subjects with liver metastases, total bilirubin (TBIL) <=3× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=5×ULN; c) Coagulation function: International normalized ratio (INR) <=1.5× upper limit of normal (ULN); Activated partial thromboplastin time (APTT) <=1.5× upper limit of normal (ULN); 7. The expected survival period is more than 6 months; 8. All patients must agree to take effective contraceptive measures during the study period and for 6 months after treatment discontinuation. Female patients of childbearing age must have a negative urine pregnancy test before treatment administration. 9. The subjects (or their legal representatives/guardians) must sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Having active bleeding or pathological conditions with a high risk of bleeding, such as known hemorrhagic diseases, coagulation disorders or tumors involving major blood vessels, hereditary bleeding tendencies or a history of thrombosis or hemorrhagic diseases; 2. Non-healing wounds, active peptic ulcers or fractures, tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intra-abdominal abscess within 6 months; 3. Uncontrolled local or systemic infections, including active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within 48 weeks before screening; 4. Have interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or active pneumonia with clinical symptoms; 5. Severe dysfunction of internal organs and myocardial infarction that occurred within the last six months; 6. Active, known or suspected autoimmune diseases (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism). Patients with vitiligo, type 1 diabetes, hypothyroidism caused by autoimmune thyroiditis that only requires hormone replacement therapy, or those who are not expected to relapse in the absence of external stimuli are allowed to be enrolled. 7. Have a history of immune deficiency, including a positive HIV test, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 8. Continuously use and require long-term use of corticosteroid hormones (>10mg/ day prednisone or equivalent dose) or other immunosuppressants within 14 days before entering the study. Inhaled or topical use of steroids and adrenal replacement steroids is permitted; 9. Subjects who have received or plan to receive live vaccines within 4 weeks before entering the study; 10. Having concurrent other malignant tumors within <=5 years prior to study enrollment, excluding fully treatable cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, local prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection; 11. It is known that there are conditions such as mental illness, alcoholism, drug abuse or substance abuse that affect informed consent and/or the expression or observation of adverse reactions; 12. Positive for HBsAg with HBV DNA detection values exceeding the upper limit of normal (1000 copies /ml or 500IU/ml), or positive for HCV (HCV RNA or HCV antibody detection indicating acute or chronic infection); 13. Those who have a history of allergy to the drug components of this plan; 14. Pregnant or lactating female patients, and women of childbearing age who refuse to take contraceptive measures; 15. The researchers determined that the patients were not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progressive free survival (PFS);Duration of Response (DoR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactGuangyuan Hu
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed