Head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:Carillizumab combined with Apatinib mesylate for injection
Sponsors
The First Medical Center of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 years, male or female; (2) Patients with stage iii-iv (according to AJCC 8th edition) head and neck squamous cell carcinoma confirmed histologically or cytologically, including oral, oropharyngeal (P16-) and hypopharyngeal carcinoma Or throat; (3) Advanced, recurrent and/or metastatic HNSCC without indications of radical therapy; Had not previously received systematic treatment for such patients; (4) The ECOG score is 0-1; (5) According to RECIST1.1, there is clinically evaluable lesion, and the target lesion is not suitable for surgical treatment or the patient refuses to accept surgical treatment; (6) Expected survival period >= 3 months; (7) The main organs function normally, without serious abnormal blood, heart, lung, liver and kidney function and immunodeficiency diseases. Specific laboratory requirements: absolute neutrophils count >= 1.5*10^9 / L; Platelet >= 100*10^9/L; Hemoglobin >= 100g/L; Serum albumin >= 30g/L; Bilirubin = 50ml/min (Cockcroft-Gault formula); Blood urea nitrogen (BUN) <= 2.5; Normal upper limit (ULN); Thyroid stimulating hormone (TSH) <= upper limit of normal value (ULN); If the abnormal level of T3 and T4 should be investigated, the normal level of T3 and T4 can be included. (8) Women of childbearing age shall undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and be voluntarily given apatinib mesylate tablets during the observation period and at the last dose Use appropriate methods of contraception within 8 weeks; For men, surgical sterilization or consent to appropriate method of contraception during observation and within 8 weeks of last administration of apatinib mesylate should be accepted. (9) The patient voluntarily joined the study and signed the informed consent (ICF); (10) Patients with compliance are expected to follow up the efficacy and adverse reactions as required by the program.
Exclusion criteria
Exclusion criteria: (1) Exposure to other anti-angiogenic small-molecule TKI drugs, such as pazoparib, sorafenib, regofinil, sildeneb, or anti-angiogenic monoclonal antibodies, such as bevacizumab;Or have used anti-pd-1 antibody, anti-ctla-4 antibody, tcr-t, car-t and other immunotherapy;Or participate in clinical trials of other anti-tumor drugs within 4 weeks before the first dose; Or within 4 weeks prior to the first administration or plan to receive the live attenuated vaccine during the study period. (2) Patients with a history of other malignancies within five years (except complete treatment of in-situ cervical cancer or basal cell carcinoma or squamous cell carcinoma). (3) Immunosuppressive drugs were used within 14 days prior to the first administration of shr-1210, excluding nasal and inhaled corticosteroids or systemic steroids in physiological doses (i.e., no more than 10 mg/ d prednisone or other corticosteroids in physiologically equivalent doses). (4) Patients with symptoms, who have spread to the gut, and who are at risk for short-term life-threatening complications (including uncontrolled exudation of large amounts of fluid [thorax, pericardium, peritoneal], pulmonary lymphangitis and more than 30% of patients with liver involvement. (5) Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis and sag somatitis, vasculitis, nephritis, hyperthyroidism and decreased thyroid function; the subjects had vitiligo or had complete remission of asthma in childhood and did not need any intervention in adulthood include; Subjects will need bronchodilators, but asthma with medical intervention will not be included.) (6) Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90mmHg, despite best medical treatment). (7) With myocardial ischemia and myocardial infarction II class above, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher). According to the NYHA standard, III ~IV cardiac insufficiency, or heart colour to exceed examination prompt left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT>1.5ULN), bleeding tendency or undergoing thrombolysis or anticoagulant therapy. (9) Patients with significant cough blood or daily hemoptysis up to half teaspoon (2.5ml) or more within 2 months before entering the study; Or 3 months before entering the study, he or she had significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occultation ++ or above, or had vasculitis, etc.; Or an arteriovenous thrombotic event that occurred within 6 months prior to study entry, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc. (10) Severe infection occurred within 4 weeks prior to the first administration (e.g., antibiotics, antifungal or antiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;OSR; | — |
Countries
China
Contacts
Public ContactPeng Liang
PLA General Hospital
Outcome results
None listed