Advanced tongue squamous cell carcinoma
Conditions
Interventions
Case group:None
Control group:None
Sponsors
Hospital of stomatology, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Case group: 1. Patients with primary TSCC confirmed by histology or cytology, where the primary lesion boundary is located at the midline of the tongue body or crosses the midline; 2. Undergo radical surgery after receiving at least 2 cycles of neoadjuvant immunochemotherapy (PD-1/PD-L1 inhibitor combined with platinum-based + taxane-based regimen), and postoperative pathology confirms negative resection margins (R0 resection); 3. Previously, no anti-tumor treatment for tongue cancer has been received, including but not limited to surgical treatment, radiotherapy, drug therapy, and biotherapy; 4. Before treatment, according to RECIST 1.1, there were clinically assessable lesions that met the criteria for downstaging surgery; 5. Be aged between 18 and 80 years old at the time of signing the informed consent form, with no gender restrictions; 6. ECOG (Eastern Cooperative Oncology Group) score of 0-1; 7. Expected survival time >= 6 months (this criterion overlaps with other inclusion criteria, and the following criteria must also be met: vital organ function meets inclusion criterion 8, no involvement of the internal carotid artery by oral or oropharyngeal cancer, no subcutaneous metastatic tumors; no distant metastasis); 8. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 7 days): (1) Normal bone marrow reserve function, with 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, and 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) =1.5cm). 3. Postoperative pathology confirmed negative margins; 4. The patient's demographic data, clinical pathological information, doctor's orders and progress notes, operating room records, and follow-up information are all complete.
Exclusion criteria
Exclusion criteria: Case group: 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 the T cell costimulatory or checkpoint pathway); 2. Have a clear history of allergies, and may potentially be allergic or intolerant to the study drug and its similar biologics; 3. Participated in other clinical trials of anti-tumor drugs within 4 weeks before the first dose; or planned to receive attenuated live vaccines within 4 weeks before the first dose or during the study period; 4. Have had oral or other malignant tumors within 5 years; 5. Immunosuppressive drugs were used within 14 days before the first use of Ticagrelor, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., not exceeding 10 mg/day of prednisolone or other corticosteroids in physiological doses equivalent to prednisolone); 6. Advanced patients with symptoms who have disseminated to internal organs and are at risk of developing life-threatening complications in the short term (including patients with uncontrollable large amounts of exudate in the chest, pericardium, or abdominal cavity; pulmonary lymphangitis; and patients with more than 30% liver involvement); 7. Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention cannot be included); 8. Patients with myocardial ischemia of grade II or above, myocardial infarction, poorly controlled arrhythmias (including QTc interval >=450ms for males and >=470ms for females), NYHA class III-IV heart failure, or left ventricular ejection fraction (LVEF) 38.5°C during screening/prior to the first dose; 10. Those with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders; 11. Subjects who have undergone major surgery or have open wounds or fractures within 4 weeks prior to the first dose; 12. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency 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 of hepatitis B and hepatitis C; 13. Presence of central nervous system metastasis; 14. Individuals with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (specific eligibility to be determined by the investigator); 15. Other situations where the researcher deems the participant unsuitable for participation in this study. Control group: 1. Previously received anti-PD-1 anti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year Recurrence-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response;Complete Pathological Response;Disease-Free Survival;Overall Survival;Swallowing and Speech Function; | — |
Countries
China
Contacts
Public ContactYang Le
Hospital of stomatology, Sun Yat-sen University
Outcome results
None listed