Oral Squamous Cell Carcinoma
Conditions
Interventions
Experiment Group:Neoadjuvant therapy: The selected subjects were treated with vedolizumab and pembrolizumab Q3W for a total of 3 cycles.
Sponsors
Peking University School of Stomatology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with primary or recurrent oral squamous cell carcinoma by pathological histology or cytology; staged as stage IV without distant metastasis according to the AJCC Cancer Staging Manual (8th Edition), planned for surgical resection or potentially resectable; 2. Plan to administer neoadjuvant therapy; 3. No prior anti-tumor therapy for head and neck squamous cell carcinoma, including but not limited to radiotherapy, drug therapy, and biological therapy; 4. Prior to treatment, there must be clinically evaluable lesions according to RECIST 1.1; 5. At the time of signing the informed consent form, the age must be >=18 years old, with no gender restrictions; 6. ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1; 7. The functions of vital organs must meet the following requirements (excluding the use of any blood components or cell growth factors within 7 days): • Normal bone marrow reserve function: white blood cell (WBC) count >=3.0×10^9/L; neutrophil count (NEUT) >=1.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=90 g/L; • Normal renal function or serum creatinine (SCr) =50 ml/min (Cockcroft-Gault formula); • 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); 8. Able and willing to comply with the research and follow-up procedures; 9. Both male and female participants of childbearing age must agree to use adequate contraceptive measures throughout the study period and for 6 months after treatment; 10. The patient voluntarily participated in this clinical study, signed the informed consent form, demonstrated good compliance, and was willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior receipt of anti-PD-1 antibodies, anti-PD-L1 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways); 2. With a known history of allergies, potentially allergic or intolerant to the investigational drug and its similar biological agents; 3. Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to the first administration; or receipt or planned administration of live attenuated vaccines within 4 weeks prior to the first administration or during the study period; 4. A history of other malignant tumors within the past 5 years (excluding well-treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin); 5. Use of immunosuppressive drugs within 14 days prior to enrollment, excluding intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., no more than 10 mg/day of prednisone or equivalent physiological doses of other corticosteroids); 6. Late-stage patients with symptoms, systemic dissemination, and a short-term risk of life-threatening complications (including those with uncontrolled massive effusions [pleural, pericardial, or ascites], pulmonary lymphangitis, or more than 30% liver involvement); 7. Presence of any active autoimmune disease or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis Hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has completely resolved during childhood and requires no intervention in adulthood can be included; subjects requiring bronchodilators for medical intervention due to asthma cannot be included; 8. Patients with myocardial ischemia or myocardial infarction of grade II or higher, poorly controlled arrhythmias (including QTc interval =450ms in males and >=470ms in females). According to NYHA criteria, those with cardiac insufficiency classified as III to IV, or those with left ventricular ejection fraction (LVEF) 38.5°C during screening or before the first administration; 10. Those with a history of substance abuse involving psychotropic drugs who cannot quit or have mental disorders; 11. Having undergone major surgical procedures or having open wounds or fractures within 4 weeks prior to the first dose; 12. Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS), active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (positive anti-HCV antibody and HCV-RNA above the detection limit of the assay method), or co-infection with both hepatitis B and C; 13. Central nervous system metastasis is present; 14. Individuals with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (specific eligibility determined by the investigator); 15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Objective response rate;2/3 year EFS rate;2/3 year OS rate;safety; | — |
Countries
China
Contacts
Public ContactWenjie Wu
Peking University School of Stomatology
Outcome results
None listed