Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Induction therapy stage: Tislelizumab, Docetaxel, and Cisplatin
Consolidation therapy stage: Tislelizumab
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: =18 years old, gender not limited; 2. ECOG score: 0-1 points; 3. Expected survival period =3 months; 4. Patients with pathologically confirmed squamous cell carcinoma of the head and neck; 5. Clinical stage classified as stage III to IVB according to the 8th edition of AJCC staging system; 6. The tumor is assessed by our hospital's multidisciplinary team for head and neck tumors as initially unresectable, including technically unresectable and functionally non-salvageable, and auxiliary examinations show no evidence of distant metastasis; 7. No prior anti-tumor treatment has been received; 8. Imaging evidence during the screening period shows that, according to the RECIST 1.1 standard assessment, there is at least one measurable target lesion; 9. Agree to provide previously stored tumor tissue specimens or undergo biopsy to collect tumor lesion tissue for IHC testing of immune-related proteins such as PD-L1; 10. Main organ functions are normal, that is, in accordance with the following standards: (1) Complete blood count: White blood cells =4×10^9/L, Neutrophils =1.5×10^9/L, Hemoglobin =90g/L, Platelets =100×10^9/L; (2) Liver function: ALT, AST < 3 times the upper limit of normal (ULN), Total bilirubin < 1.5×ULN. Child-Pugh classification is A or B, and the volume of normal liver tissue is =700cm^3; (3) Renal function: Serum creatinine < 1.5×ULN; (4) Coagulation function: INR and APTT = 1.5×ULN; (5) Serum albumin =28g/L; (6) Urine routine: Urine protein <2+ (when baseline urine protein is =2+, a 24-hour urine protein quantification test is performed within 7 days, and the patient is eligible for inclusion when the urine protein quantification is <1g); (7) Left ventricular ejection fraction (LVEF) =50%; 11. Women of childbearing age must have taken reliable contraception or undergone a pregnancy test (serum or urine) within 7 days before enrollment, and the result must be negative, and they are willing to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization; 12. Patients are able to understand and sign the informed consent form (when the subject loses the ability to act, it is signed by the legal representative), and are expected to have good compliance.
Exclusion criteria
Exclusion criteria: 1. Presence of any active autoimmune disease or history of autoimmune disease; 2. Concurrent second primary tumor (e.g., esophageal cancer, etc.); 3. Patients allergic to any medication or excipients used in the drugs; 4. Severe active infection requiring systemic treatment; 5. Within 6 months prior to the study medication, one of the following conditions occurred: myocardial infarction, severe/unstable angina, coronary artery/bypass graft surgery, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; 6. Within 28 days, there is a clear tendency to bleed or significant clinical bleeding symptoms, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis and retracted rhinorrhea), and persistent bleeding disorders or coagulation dysfunction diseases; 7. Need to use corticosteroids (greater than 10mg/day prednisone or equivalent) or equivalent alternatives within 14 days before the study treatment; 8. Within 4 weeks before the study medication or likely to receive live vaccines or undergo major surgery during the study period; 9. Pregnant or lactating women; 10. Immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive for HBV surface antigen, or positive for HCV RNA when anti-HCV antibody screening is positive). History of known active tuberculosis (TB); 11. As judged by the investigator, the subject has other factors that may lead to the study being forced to terminate prematurely, such as: severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival rate at 2 years;Progression Free Survival rate at 2 years;Adverse Events;Pathological Response Rate; | — |
Countries
China
Contacts
Public ContactQinwei Wang
Qilu Hospital of Shandong University
Outcome results
None listed