oral squamous cell carcinoma
Conditions
Interventions
tirelizumab:tirelizumab
Combination group:tirelizumab+GP
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject inclusion criteria 1) Male and female patients aged 18 to 70 years; 2) The first patient was diagnosed as 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) Stage III to IVb oral squamous cell carcinoma (T1-2N1-3M0, T3-4aN0-3M0) whose primary focus can be completely resected; 4) Remote metastasis was excluded by chest CT and whole body bone radionuclide scanning. 5) The function of vital organs is normal and can tolerate the formulated treatment plan: a) Absolute neutrophil count =1.8×109/L; b) Platelet count =100×109/L; c) Hemoglobin =9 g/dL; d) Serum albumin =3 g/dL; e) Bilirubin =1.5 times the normal upper limit; f) Aspartic acid and alanine aminotransferase =2.5 times the normal upper limit; g) International standardized ratio of prothrombin time =1.5; h) leukocyte =2000/µL; i) Serum creatinine =1.5 times the normal upper limit; j) Thyroid stimulating hormone = normal upper limit. 6) The performance status on ECOG performance scale of physical state is 0-1; 7) Women of reproductive age (18-49 years of age) who have a negative serum or urinary HCG test for 7 days prior to treatment and who agree to use medically approved measures for contraception during treatment and for 120 days after treatment; 8) Sign informed consent and voluntarily participate in the clinical trial research project.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) Subjects who had previously experienced grade 3 immune-related adverse events or treatment-induced adverse events that did not recover to = grade 1; 2) Surgery, chemotherapy, targeted small molecule therapy, or radiotherapy for another aggressive malignancy within the past 5 years; 3) Have been treated with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-ctLA-4 antibodies or any other antibodies or drugs that target T cells or immune checkpoint pathways; 4) Have an autoimmune disease requiring systemic steroid therapy within the past 3 months, or have a history of clinically severe autoimmune disease, or have a syndrome requiring systemic steroid therapy; 5) Active infection requiring systemic treatment; 6) Use of psychotropic drugs or drug abuse, which will interfere with the test; 7) Patients with a history of other (including unknown primary) malignancies within 5 years prior to initial administration 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; 8) The patient has any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic disease; 9) Use of any vaccine against infectious diseases (e.g., influenza, chickenpox) within 4 weeks (28 days) prior to the start of study treatment or receive live or attenuated vaccine within 30 days prior to the initial administration of triprilimab, or plan to receive live or attenuated vaccine during the study period; 10) Subjects with 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 value); 11) Patients known to be allergic to the investigational drug or its active ingredient or excipients; 12) Patients with underlying hematological problems, including bleeding diathesis, known prior gastrointestinal bleeding that required intervention within the past 6 months, and active pulmonary embolism or deep vein thrombosis (DVT) that are unstable in anticoagulant regiments; 13) Known history or any evidence of active non-communicable pneumonia; 14) Known active central nervous system (CNS) metastases and/or cancerous meningitis or pia. Subjects 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), no evidence of new or enlarged brain metastases, and no steroid use at least seven days prior to trial treatment. This exception does not cover cancerous meningitis, which is excluded regardless of clinical stability; 15) Concurrent (or receive) treatment with drugs that may affect drug metabolism within 7 days prior to the first day of Cycle 1; 16) Pregnancy or lactation, or expect to become pregnant or have a child during the expected trial period, beginning with a pre-screening or screening visit 120 days after the last dose of trial treatment. 17) Any circumstances that the investigator deems inappropriate for other reasons or that may interfere with t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR;pCR;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DFS; | — |
Countries
China
Contacts
Public ContactHongyu Yang
Peking University Shenzhen Hospital
Outcome results
None listed