oral squamous cell carcinoma
Conditions
Interventions
CAP group:The surgical field wound was irradiated with plasma during the operation, and the surgical field was irradiated with plasma after the operation.
Control group:None
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 70 years, no gender limit; 2. The first patient was diagnosed with squamous cell carcinoma by pathological examination, and the incidence sites were tongue, floor of mouth, gum, buccal mucosa, hard palate, and posterior molar region; 3. Oral squamous cell carcinoma whose primary focus can be completely resected; 4. Remote metastasis was excluded by chest CT and whole body bone radionuclide scanning; 5. Vital organ function is normal and can tolerate the treatment plan: (1) Absolute neutrophil count >=1.8x10^9/L; (2) Platelet count >=100x10^9/L; (3) Hemoglobin >=9 g/dL; (4) Serum albumin >=3 g/dL; (5) Bilirubin =2000/µL; (9) Serum creatinine <=1.5 times the normal upper limit; (10) Thyroid stimulating hormone <= normal upper limit; 6. The performance status on ECOG performance scale of physical condition is 0-1; 7. Women of childbearing age (18-49 years) who have tested negative for serum or urinary HCG within 7 days prior to treatment and have consented to use medically approved measures for contraception during treatment and for 120 days after the end of treatment; 8. Sign informed consent and voluntarily participate in the clinical trial research project.
Exclusion criteria
Exclusion criteria: 1. Patients who had previously experienced grade >=3 immune-related adverse events or treatment-induced adverse events that did not recover to grade <=1; 2. Received surgery, chemotherapy, targeted small molecule therapy, or radiotherapy for another aggressive malignancy within the past 5 years; 3. There is an active infection that requires systemic treatment; 4. Use of psychotropic drugs or substance abuse, which may interfere with the trial; 5. Patients with a history of other malignancies (including unknown primary) within 5 years prior to the first dosing of the trial treatment. Note: Except for adequately treated stage 1 or 2 basal/squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ undergoing potentially curable therapy; 6. The patient has any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring medical treatment, liver, kidney or metabolic disease; 7. The patient has congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (Hepatitis B: HBV DNA test value exceeds the upper limit of normal value; Hepatitis C: HCV virus titer or RNA test value exceeds the upper limit of normal); 8. Patients who are known to be allergic to plasma components or their active ingredients and excipients; 9. Patients with underlying hematological problems, including bleeding diathesis, known prior gastrointestinal bleeding that required intervention within the last 6 months, and active pulmonary embolism or deep vein thrombosis (DVT) that are unstable on an anticoagulant regimen; 10. Known history or any evidence of active non-communicable pneumonia; 11. Known active central nervous system (CNS) metastases and/or cancerous meningitis or pia. Patients with previously treated BMS may participate as long as they are stable (no evidence of imaging progression at least four weeks prior to the first trial treatment and any neurological symptoms have returned to baseline), have no evidence of new or enlarged brain metastases, and have not used steroids for at least seven days prior to the trial treatment. This exception does not include cancerous meningitis, which is excluded regardless of clinical stability; 12. Pregnant or lactating, or expecting to become pregnant or give birth during the expected trial period, beginning with a pre-screening or screening visit 120 days after the last dose of trial treatment; 13. Any circumstances that the investigator deems unsuitable for participation in the trial for other reasons or that may interfere with the patient's participation in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Complication rate; | — |
Countries
China
Contacts
Public ContactWang Yufan
Peking University Shenzhen Hospital
Outcome results
None listed