Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial

Korábbi kezelés

• Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
• Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.
• Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
• Serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose.
• Participation in other clinical trials within 30 days before enrollment

Más betegség

• Known history of malignancy, unless been cured and no recurrence for 5 years
• Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
• Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.
• Known human immunodeficiency virus (HIV) infection
• Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection).
• History of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis.
• Known allergic reaction to any ingredients or excipients of the therapy

Egyéb

• Pregnant or lactating women
• Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial

• Signed the informed consent form
• Histopathological diagnosis of oral squamous cell carcinoma
• Age: 18-75 years old , Gender: male and female
• Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
• No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors, VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.);
• Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Adequte organ function based on laboratory test values obtained during the screening period：1）Blood routine: white blood cells (WBCs) >3.0× 109/L, ANC >1.5× 109/L, platelets >75× 109/L, hemoglobin >9 g/L, 2）Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal，3）Renal function: Serum creatinine <1.5 times the upper limit of normal，4）Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal，5）Left ventricular ejection fraction (LVEF) ≥ 50%
• contraception