Recurrent or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Group A:camrelizumab combined with chemotherapy
Group B:camrelizumab combined with Apatinib Mesylate
Sponsors
the Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender; 2. Newly diagnosed locally advanced, recurrent or metastatic head and neck squamous cell carcinoma confirmed by histology or cytology and cannot be cured by local treatment (primary tumor sites are the oropharynx, oral cavity, hypopharynx and larynx), recurrence or metastasis stage Have not received any anti-tumor system treatment (allowed as part of locally advanced tumor treatment, and it takes more than 6 months from the end of the treatment to the signing of the informed consent); 3. The ECOG score is 0 or 1; 4. Expected survival period >= 12 weeks; 5. According to the RECIST 1.1 standard, there is at least one measurable lesion, and a lesion that has been treated with previous radiation can also be used as a measurable lesion if the disease progresses; 6. Tumor tissues for PD-L1 detection (paraffin specimens or fresh tumor tissues within 2 years) can be provided; 7. Subjects with oropharyngeal cancer provide P16 detection status, using IHC method; 8. The subject may have a history of brain/meningeal metastasis, but must undergo local treatment (surgery/radiotherapy) before the start of the study, and be clinically stable for at least 3 months (allowed to use corticosteroids before the first use of the study drug, but the drug needs to be stopped 2 weeks before the study); 9. The organ function level must meet the following requirements (14 days before the first administration of the study drug): (1) Bone marrow: Absolute neutrophil count (ANC) >= 1.5x10^9/L, platelet (PLT) >= 100x10^9/L, hemoglobin (HB) >= 9g/dL (no blood transfusion or receiving components within 14 days before the test) Blood); (2) Liver: serum total bilirubin (TBIL) =50mL/min (Cockcroft-Gault formula); (4) International normalized ratio (INR), activated partial thromboplastin time (APTT) 1+, need to be collected For 24-hour urine protein determination, the total amount needs to be <=1g; (6) The heart function is normal, that is, the ECG is normal or abnormal and has no clinical significance, and the echocardiography shows that the left ventricular ejection fraction (LVEF) is greater than 50%; 10. Female subjects with reproductive ability must have a negative serum pregnancy test result before the first administration of the test drug; male or female subjects with reproductive ability must use highly effective contraceptive methods (such as oral Contraceptives, intrauterine contraceptives, sex control or barrier contraception combined with spermicide), and continue contraception for 90 days after the end of treatment; 11. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and co
Exclusion criteria
Exclusion criteria: 1. Progression within 6 months after systemic treatment for locally advanced head and neck squamous cell carcinoma; 2. Previous history of primary tumor of nasopharyngeal carcinoma; 3. Intolerable to platinum-based therapy (only for cohort A); 4. Previous treatment with platinum-based regimen and disease progression (only for cohort A); 5. Patients who participated in or were participating in other drug/therapy clinical trials 4 weeks before the first dose of study drug; 6. Patients who underwent major surgery or had not recovered from the side effects of this surgery; patients who has accepted live vaccination, immunotherapy, or patients who underwent radiotherapy within 2 weeks; 7. Patients who received any other anti-tumor treatment; 8. Patients with any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo without systemic treatment can be included; in childhood asthma has been completely relieved, adults who do not require any intervention can be included; patients with asthma who require bronchodilators for medical intervention cannot be included); 9. Patients who are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other effective hormones), and continue to use within 2 weeks before enrollment; 10. History of other malignant tumors within the past 5 years, except cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, early prostate cancer and cervical carcinoma in situ; 11. Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin and other treatments within 1 week before the first dose of study drug; 12. Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies or activating or inhibiting drugs against T cell receptors (e.g. OX40, CD137); 13. Presence of active or uncontrolled metastatic central nervous system tumor lesions diagnosed by imaging; 14. Positive test results for HIV antibody or Treponema pallidum antibody; 15. Patients with active hepatitis B or C, if HBsAg or HBcAb is positive, HBV DNA should be measured (the measured result is higher than the upper limit of normal range), if the test result of HCV antibody is positive, additionally test HCV RNA (the test result is higher than the upper limit of normal range); 16. Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; 17. A large amount of pleural effusion or ascites requiring symptomatic treatment and accompanied by clinical symptoms; 18. Active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or history of active pulmonary tuberculosis; 19. Patients with any uncontrolled clinical problems, including but not limited to: persistent or active (severe) infection; hypertension poorly controlled by drugs (blood pressure persistently greater than 150/90 mmHg); poorly controlled diabetes; heart disease (grade III/IV congestive heart failure or heart block defined by New York Heart Association); the following conditions within 6 months before the first dose: deep venous thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; coronary intervention, acute coro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Duration of remission;Disease control rate;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactZhang Chenping, Ren Guoxin
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed