Head and neck squamous cell carcinoma
Conditions
Interventions
the treatment group:Zimberelimab combine with Androtinib + Paclitaxel-albumin + Cisplatin/Carboplatin
Sponsors
Beijing Chaoyang Sanhuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participation in clinical research and signing of informed consent; 2. Age >= 18 years and = 3 months; 8. At least one measurable lesion (according to RECIST v1.1); 9. The patient must be able to swallow the oral drug without obvious gastrointestinal abnormalities. 10. The main organs have sufficient functions; 11. The investigator assessed that the heart and lung functions were normal; 12. The blood pressure is normal, and the blood pressure of patients with hypertension is well controlled (no higher than 140/90 mmHg); 13. There is no obvious contraindication of chemotherapy, anti angiogenic therapy and immunotherapy; 14. Take effective contraceptive measures voluntarily during the study treatment period and within 120 days after the treatment; 15. Women of childbearing age must have taken reliable contraceptive measures, conducted blood pregnancy test within 7 days before enrollment, and the result is negative.
Exclusion criteria
Exclusion criteria: 1. The primary lesion is not clear; 2. Disease progression (PD) occurs within six months after completing the expected curative systemic treatment for locally advanced HNSCC; 3. Have received radiotherapy (or other non systemic treatment) within 2 weeks before enrollment or have not fully recovered from adverse events due to previous treatment; 4. Have received anti PD-1/PD-L1 antibody, anti PD-L2 antibody, CTLA-4 antibody, or other drugs/antibodies acting on T cell co stimulation or checkpoint access in the past; 5. Patients with severe active autoimmune diseases who need glucocorticoid or systemic immunosuppression treatment within 2 years before the first administration. Patients whose diseases have been controlled and do not need systemic immunosuppressive treatment are allowed to be included in the group, such as type I diabetes, hypothyroidism that only needs hormone replacement treatment, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis, and alopecia); 6. Have congenital or acquired immune function defects (such as HIV infection), active hepatitis B (HBV-DNA >= 1*104 copies/ml or 2000 IU/ml) or hepatitis C (hepatitis C antibody is positive and HCV RNA is higher than the detection limit of the analytical method); 7. There are infectious diseases within 14 days before the first administration, and systemic anti infection treatment is required; 8. Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressants for systematic treatment within 14 days before the first administration of the study drug or during the study. In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids, or replace adrenal hormones with a dose 480ms, QTc interval calculated by Fridericia formula) occurred within 6 months before the first administration; 12. Evaluated by the investigator, the patient has undergone major surgery and has not recovered within 28 days before the first administration; 13. Have a history of major vascular disease or bleeding disease within 6 months before the first administration (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, portal hypertension accompanied by gastrointestinal bleeding, etc.); 14. Any other malignant tumor was diagnosed within 3 years before entering the study, except for skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer carcinoma, cervical carcinoma in situ, breast intraductal carcinoma in situ and thyroid papillary carcinoma that can be treated locally and have been cured; 15. Previous or planned organ transplantation (including bone marrow transplantation); 16. Inoculate live vaccine (inactivated vaccine is allowed) within 4 weeks before the first use of the study drug; 17. Participated in other c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, DCR;Progression-Free-Survival, PFS;overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactPi Jinping
Beijing Chaoyang Sanhuan Cancer Hospital
Outcome results
None listed