Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experiment group:Camrelizumab+chemotherapy + surgery± radiotherapy ± chemotherapy +camrelizumab
Control group:Surgery ±radiotherapy±chemotherapy
Sponsors
Shanghai 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 years and =4.0x10^9/L, ANC>=1.5x10^9/L,PLT>=100×10^9/L,Hb>=90g/L (No blood transfusion or blood products within 14 days, and no use of G-CSF or other hematopoietic stimulants for correction) (2). Biochemical examination: Serum albumin >= 3.0 g/dL (30 g/L), TBIL <= 1.5ULN, ALT, AST <= 2.5 × ULN, BUN and CRE <= 1.5 × ULN or endogenous creatinine clearance rate = 60ml/min (Cockcroft Gault formula); (3). Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 times ULN; for participants receiving anticoagulant therapy, PT within the intended range of use of the anticoagulant drug; 9. Women of childbearing potential must have a negative ß-HCG pregnancy test within 7 days prior to the administration of the first study treatment and are willing to use effective contraception methods during the trial period and within 2 months after the last administration of anti-PD-1 antibody. For male participants whose partners are women of childbearing potential, effective contraception methods should be used during the trial period and within 2 months after the last administration of anti-PD-1 antibodies; 10. Participants voluntarily joined the study, signed informed consent, with good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies that act on T cell co stimulations or checkpoint pathways; 2. Presence of severe active autoimmune diseases. Subjects with stable conditions not requiring systemic immunosuppressive therapy are allowed for enrollment, such as: type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia); 3. History of congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA); 4. History of hypersensitivity to study drug or any excipients or to other humanized mAbs; 5. The following conditions occurred within 6 months before randomization: myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia and symptomatic congestive heart failure; 6. Live vaccines have been vaccinated within 4 weeks before the first use of the study drug. Inactivated virus vaccines for seasonal influenza and injections are allowed, but live attenuated influenza vaccines for nasal use are not allowed. 7. History of allogeneic organ transplant or allogeneic hematopoietic stem cell transplantation; 8. History of psychotropic drug abuse or narcotic drug abuse; 9. Pregnant or breast-feeding women; 10. History of another primary malignancy within 5 years except for tumors that can be treated locally and cured such as skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ and papillary thyroid carcinoma; 11. Patients with other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study. And the patients that the researchers think are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Two year overall survival rate;Five year event-free survival rate;Five year overall survival rate;Pathologic complete response rate;Major Pathological Response Rate;Two year and five year distant metastasis-free survival rate;Two year and five year locoregional recurrence-free survival;Safety; | — |
Countries
China
Contacts
Public ContactYue He, Yanjie Zhang
The Ninth People's Hospital Affiliated to Medical School of Shanghai Jiaotong University
Outcome results
None listed