Locally advanced (clinical stage III, IVA and IVB according to AJCC clinical stage) oral squamous cell carcinoma
Conditions
Interventions
low-dose radiotherapy:Low-dose radiotherapy
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 years old (inclusive) to 70 years old (inclusive) at the time of enrollment, based on the date of birth in the Gregorian calendar, and the age calculation is up to the day of signing the informed consent form; Including both male and female; 2. ECOG score: 0-1 points; 3. Expected survival period > = 6 months; 4. Patients with pathologically confirmed oral squamous cell carcinoma; 5. Patients who meet the clinical stage III, IVA and IVB according to the clinical stage of AJCC; 6. No evidence of distant metastasis shown by auxiliary examination; 7. No previous anti-tumor treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy; 8. Radiographic evidence during the screening period showing at least one measurable target lesion as assessed according to RECIST1.1 criteria; 9. Agree to provide previously stored tumor tissue specimens or perform biopsy to collect tumor lesion tissue for PD-L1 IHC testing; 10. Normal function of major organs, that is, meeting the following criteria: (1) Blood routine: leukocyte >=4×10^9/L, neutrophil >=1.5×10^9/L, hemoglobin >=90g/L, platelet >=100×10^9/L; (2) Liver function: ALT, AST=700cm^3; (3) Renal function: serum creatinine =28g/L; (6) Urine routine: urine protein =2, 24-hour urine protein quantification test will be performed within 7 days, and only when urine protein quantification =50%; 11. Women of childbearing potential must have taken reliable contraception or have a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of trial drug. For men, agree to use an appropriate method of contraception or be surgically sterile during the trial and for 8 weeks after the last dose of trial drug; 12. Patients are able to understand and sign the informed consent form (signed by their legal representative when the study participant becomes incapacitated) and is expected to have good compliance.
Exclusion criteria
Exclusion criteria: 1. Not suitable for low-dose radiotherapy, immunotherapy and chemotherapy as specified in the protocol; 2. Previous anti-tumor therapy, including investigational drugs, chemotherapy, radiotherapy, or previous antibody or drug therapy against anti-PD-1, anti-PD-L1, anti-PD-L2 or any other specific targeting T cell cost-stimulatory checkpoint pathway; 3. Severe active infection requiring systemic treatment; 4. One of the following conditions within 6 months before study medication: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; 5. Presence of clear bleeding tendency or significant clinically significant bleeding symptoms within 28 days, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis bleeding and retracted nasal nose), and persistent bleeding disorders or coagulation dysfunction diseases; 6. Need to use cortisol (greater than 10mg/day prednisone or equivalent) or prednisone or equivalent at a dose greater than 10mg/day or equivalent of replacement therapy within 14 days prior to study treatment; 7. Vaccination of live vaccines or major surgery within 4 weeks before study drug use or possible during the study; 8. Pregnant or lactating women; 9. Immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related disease, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV surface antigen positive, or HCV RNA positive when anti-HCV antibody screening test is positive). Have a known history of active pulmonary tuberculosis (TB); 10. According to the investigator's judgment, the study participant has other factors that may lead to the forced termination of this study, such as serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the study participants, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response rate of patients with locally advanced oral squamous cell carcinoma treated with low-dose radiotherapy combined with chemotherapy and immune neoadjuvant therapy;Major pathological response rate (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year event-free survival rate (EFS rate);objective response rate (ORR);oral function preservation rate;2-year overall survival rate (OS rate);Safety; | — |
Countries
China
Contacts
Public ContactChen Anwei
Qilu Hospital of Shandong University
Outcome results
None listed