Locally advanced oral squamous cell carcinoma
Conditions
Interventions
Single arm treatment group:First of all, patients were treated with 2-cycle regimen of camrelizumab plus (200 mg, D1, ivgtt)+albumin paclitaxel (260 mg/m^2, D1, ivgtt)+cisplatin (75 mg/m^2, divided in
Then carry out radical operation
Finally, postoperative adjuvant radiotherapy (chemotherapy) combined with maintenance therapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Histopathological diagnosis of oral squamous cell carcinoma (including tongue cancer, gingival cancer, buccal mucosal cancer, oral floor cancer, and posterior triangular area tumor of molars); 3. Patients with locally advanced oral squamous cell carcinoma (classified as stage III-IVB according to the 8th edition of UICC/AJCC staging); 4. KPS score >= 70 points; 5. Have not received any relevant treatment in the past; 6. No distant metastasis; 7. The patient intends for curative treatment; 8. Good hematopoietic function (total white blood cell count >= 3.5 × 10^9/L, absolute lymphocyte count >= 0.8 × 10^9/L, absolute neutrophil count >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, hemoglobin >= 90g/L); 9. Good liver function (bilirubin level = 60 ml/min (Cockcroft Gault formula), urine protein content less than 2+on urine routine examination, or 24-hour urine protein quantification<1g); 11. Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN. If the subject is receiving anticoagulant therapy, as long as the PT is within the intended range of use of the anticoagulant drug, it is sufficient; 12. No severe organic heart disease or arrhythmia; 13. Women of childbearing age (15-49 years old) must undergo pregnancy studies within 7 days before starting treatment and the results must be negative; Male and female patients with fertility must agree to use effective contraceptive measures to ensure that they do not become pregnant during the study period and within 3 months after discontinuing treatment;
Exclusion criteria
Exclusion criteria: 1. With previous any other form of anti-tumor treatment; 2. Patients with allergic constitution and congenital immunodeficiency; 3. Active infection; 4. With previous organ transplantation; 5. With a history of autoimmune diseases, or other diseases need long-term systemic use of hormone drugs or immunosuppressive treatment; 6. Human immunodeficiency virus (HIV) positive; 7. Active hepatitis B or C infection (HBV DNA and HCV RNA exceed the upper limit of normal value); 8. Total number of white blood cells 1.5 times the upper limit of normal value, transaminases (AST, ALT)>3 times the upper limit of normal value (if liver metastasis is 5 times the upper limit of normal value), and serum creatinine>1.5 times the upper limit of normal value; Coagulation function is abnormal, international normalized ratio (INR) or prothrombin time (PT) is more than 1.5 times of the upper limit of normal value; 9. Serious cardiovascular, respiratory or immune system diseases; Including urinary tract obstruction, positive heart load test, myocardial infarction, arrhythmia, obstructive or restrictive pulmonary disease, or other diseases that the investigator believes may increase the risk of the subject; 10. Pregnant or lactating women; 11. The patient does not agree to use effective contraceptives during the treatment period and the following 3 months; 12. Patients participating in other clinical studies at the same time; 13. Patients who are seriously ill and cannot complete the investigation; 14. People with a history of mental illness (such as schizophrenia, mania, anxiety, depression, phobia, etc.) or patients or spouses who were diagnosed with mental illness when they were enrolled in the clinical trial; 15. Patients or spouses who are unable to answer normally due to confusion, aphasia, mental retardation and other reasons; 16. Other malignant tumor diseases; 17.The researcher believes that there are other factors that are not suitable for inclusion or affect the participation or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease-free survival;Overall survival;The correlation between pathological remission and survival period; | — |
Countries
China
Contacts
Public ContactLei Liu
West China Hospital of Sichuan University
Outcome results
None listed