oral cavity or oropharynx carcinoma
Conditions
Interventions
Experiment Group:Neoadjuvant therapy: Tislelizumab, cisplatin, paclitaxel. Surgery. Adjuvant therapy: RT or cCRT.
Sponsors
Peking University Hospital of Stomatology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in the trial: 1. Histologically or cytologically confirmed squamous cell carcinoma, stage III-IV locally advanced oral or oropharyngeal cancer, planned surgical resection or potentially operable; 2. Plan for neoadjuvant therapy; 3. No previous treatment for oral cancer; 4. Have clinically assessable lesions according to RECIST1.1 before treatment; 5. The age when signing the informed consent form is 18 to 80 years old, and the gender is not limited; 6. ECOG score is 0-1; 7. Expected survival time >= 6 months; 8. The function of vital organs meets the following requirements (excluding any blood components and cell growth factors within 7 days): (1) Normal bone marrow reserve function, white blood cell (WBC) >= 3.0 x 10^9/L; neutrophil count (NEUT) >= 1.5 x 10^9/L, platelet count (PLT) >= 100 x 10^9/L, hemoglobin (Hb) >= 90 g/L; (2) Normal renal function or serum creatinine (SCr) = 50 ml/min (Cockcroft-Gault formula); (3) Normal liver function or total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels <= 2.5 times the upper limit of normal (ULN); 9. Able and willing to comply with research and follow-up procedures; 10. Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment; 11. The patients voluntarily joined the clinical study and signed the informed consent form. The compliance was good and they could cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: If one of the following situations occurs, you will not be selected: 1. Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway); 2. Have a clear history of allergies, and may have potential allergies or intolerances to the study drug and its similar biological agents; 3. Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first dose; or planned to receive live attenuated vaccines within 4 weeks before the first dose or during the study; 4. Other malignant tumors have occurred within 5 years (except for fully treated skin squamous cell carcinoma or controlled skin basal cell carcinoma); 5. Use of immunosuppressive drugs within 14 days before the first use of tislelizumab, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day prednisolone or other corticosteroids at equivalent pharmacological doses); 6. Symptomatic, advanced patients with visceral dissemination who are at risk of life-threatening complications in the short term (including uncontrolled massive exudates [thoracic, pericardium, abdominal], pulmonary lymphangitis, and 30 % or more of patients with liver involvement); 7. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function Hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included); 8. Patients with myocardial ischemia or myocardial infarction above grade II, and poorly controlled arrhythmias (including QTc interval >= 450ms for men and >= 470ms for women). According to the NYHA standard, patients with grade III-IV cardiac insufficiency, or echocardiography showed left ventricular ejection fraction (LVEF) 38.5°C during the screening period/before the first dose; 10. Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; 11. Major surgery within 4 weeks before the first dose. or have an open wound or fracture; 12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV- RNA above the detection limit of the analytical method) or co-infection with hepatitis B and C; 13. There is central nervous system transfer; 14. Those with a history of hereditary or acquired hemorrhage or coagulation dysfunction (specifically, whether or not to be selected by the investigator); 15. Other circumstances that the researcher judges unsuitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response, PCR;Objective response rate, ORR;Event-free survival, EFS;Event-free survival, EFS;Overall survival, OS;Progression-free survival, PFS;Progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactZhang Jie
Peking University Hospital of Stomatology
Outcome results
None listed