Oral squamous cell carcinoma
Conditions
Interventions
Experimental Group:Pembrolizumab: 200mg, intravenous drip, with each treatment cycle lasting 3 weeks, for a total of 8 cycles.
Sponsors
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years old, gender not limited. 2.The histological diagnosis was oral squamous cell carcinoma. Based on the UICC/AJCC TNM staging (8th Edition), the postoperative pathological stage was IVa (N2). 3.Immunohistochemical detection of histological specimens showed that PD-L1 CPS>1. 4. The patient has undergone radical resection of the primary oral tumor and radical cervical lymph node dissection. After the operation, they received adjuvant radiotherapy for the oral tumor bed area and the neck. 5.The Eastern Cancer Collaboration (ECOG) score is 0 to 1. 6. Normal functions of major organs, meeting the following criteria: Blood routine: Hemoglobin (HB)>=9 g/dL; The absolute neutrophil count (ANC) is >=1.5 × 10^9/L, and the platelet count (PLT) is >=100 × 10^9/L. Blood biochemistry: Serum total bilirubin (TBIL)50 mL/min (Cockcroft-Gault formula). 7. Expected survival period >=6 months. 8. The serum pregnancy test results of fertile female subjects before the first administration of the investigational drug must be negative. 9.Male patients with fertility and female patients with fertility at risk of pregnancy must agree to contraception throughout the study period. 10. Agree to undergo ctDNA-MRD testing of peripheral blood samples during the treatment period. 11. Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously received treatment with PD - (L) 1 inhibitors. 2. It has been confirmed that there is an allergy to pembrolizumab or its excipients. 3. Active bleeding or pathological conditions with a high risk of bleeding, such as known bleeding disorders, coagulation dysfunction, tumors involving large blood vessels, hereditary bleeding tendencies, or a history of thrombosis or bleeding; 4. Non healing wounds, active peptic ulcers or fractures, with tracheoesophageal fistula, gastrointestinal perforation or fistula, and intra-abdominal abscess within 6 months; 5. Local or systemic infections that are not adequately controlled, including active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within 48 weeks prior to screening; 6. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or active pneumonia with clinical symptoms; 7. Severe visceral organ dysfunction and myocardial infarction that has occurred in the past 6 months; 8. Active, known or suspected autoimmune diseases (such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism). Allowing vitiligo, type I diabetes, hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy only, or expected not to recur in the absence of external stimuli to be included in the group; 9. History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10. Continuous use of corticosteroids (>10mg/day prednisone or equivalent dose) or other immunosuppressive agents is required within = 14 days prior to entering the study. Allow inhalation or topical use of steroids and adrenal replacement steroids; 11. Subjects who have received or plan to receive live vaccines within 4 weeks prior to entering the study; 12. Previous or concurrent presence of other malignant tumors (excluding those that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc.). 13. Known history of substance abuse, alcohol or drug use. 14. Pregnant or lactating women. 15. There are other factors that may cause the subject to be forced to terminate the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactJing Zhao
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed