Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
Participant Group:Tislelizumab(PD-1 monoclonal antibody) and TP chemotherapy combined with Stereotactic Body Radiotherapy(SBRT)
Sponsors
The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging II-IVB, according to the eighth edition of the AJCC staging system;Patients who are recommended to perform surgery; (2).Patients between 18 and 70 years old; (3).ECOG: 0~1 points; (4).The major organs meet the following standards (no blood components and cell growth factors are injected within 14 days): a. neutrophil ANC=1.0×10^9/L; Hemoglobin HB=90 g/L;platelet count PLT=75×109/L; Serum albumin =28g/L; b. alanine aminotransferase ALT, aspartate aminotransferase AST=1.5×upper limit of normal;Total bilirubin TBIL=1.5×upper limit of normal, c. creatinine clearance =50 mL/min; d.Activated partial thromboplastin time (APTT) and international normalized ratio (INR) = 1.5 × upper limit of normal (for the use of stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin, and INR in the anticoagulant expected treatment can be filtered within the scope); (5). At least one measurable lesion should be detected according to the RECIST 1.1; (6). Estimated survival time = 3 months; (7).Women of childbearing age should take contraceptive measures during the medication period and within 6 months after the medication; and the male should agree to take contraceptive measures during the study period and within 6 months after the end of the study period; (8)The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: (1) A history of allergies to PD-1 inhibitors or any of albumin-bound paclitaxel or cisplatin. (2) A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma. (3) Uncontrolled cardiac clinical symptoms or diseases, such as :(a) NYHA class II or higher heart failure, (b) unstable angina pectoris, (c) myocardial infarction within 1 year, and (d) patients with clinically significant ventricular or ventricular arrhythmias requiring intervention. (4) Have received any of the following treatments: (a) Any research drug received prior to the first dose of the current research drug. (b) Joined another clinical study at the same time, unless it is an observational (noninterventional) clinical study or an intervention during a follow-up. (c) Needed systemic treatment with corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergies or nausea and vomiting. In the absence of active autoimmune diseases, inhalation or partial use of steroids and adrenal corticosteroid replacements at doses greater than 10 mg per day of adrenal corticosteroid equivalent is permitted. (d) Live vaccines were administered within 4 weeks prior to the first administration of research drugs. (e) Major surgery or severe trauma within four weeks of initial use of the study drug. (5) Serious infections (greater than grade 2 according to the Common Terminology Criteria for Adverse Events), such as severe pneumonia, bacteremia, and infection comorbidities, which required hospitalization, occurred within 4 weeks prior to the first dose of the study drug; baseline chest imaging examinations indicate the presence of active lung inflammation or symptoms and signs of infection within 2 weeks prior to the first dose of the study drug or indicate the need for oral or intravenous antibiotic treatment (excluding the use of preventive antibiotics). (6) A history of active autoimmune diseases and syndromes (including, but not limited to, interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo or cured childhood asthma/allergies that do not require any intervention in adulthood are not excluded. (7) A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation. (8) Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment. (9) (10)Active hepatitis B (HBV DNA = 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection). (10) Known history of psychotropic drug abuse, alcoholism and drug use. (11) Pregnant or lactating women. (12) Not suitable for inclusion, as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response rate(pCR rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Major pathological response rate;Non-surgery-delay rate; | — |
Countries
China
Contacts
Public ContactLiu Zhigang
The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital)
Outcome results
None listed