Locally advanced, initially treated tongue squamous cell carcinoma
Conditions
Interventions
Intervention gro:Paclitaxel-based drug (Albumin-bound Paclitaxel, 260mg/m2
or Paclitaxel 175mg/m2
or Docetaxel 75mg/m2) + Cisplatin, 75mg/m2 + Tislelizumab, 200mg, Q3W, iv drip, 2 cycles
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Histologically or cytologically diagnosed tongue squamous cell carcinoma, with a TNM stage of T3-4aN0-3M0; b. Have not received any systematic and/or local treatment for the current disease in the past; c. Sex unlimited, age 18-75; d. ECOG score 0-1; e. According to the evaluation standard of solid tumor curative effect (RECIST 1.1), there is at least one imaging measurable lesion; f. Expected survival time > 6 months; g. Sufficient organ function, subject shall meet the following laboratory indicators: 1) Absolute neutrophil count (ANC) = 1.5x109/L without using granulocyte colony stimulating factor in recent 14 days; 2) Platelets = 100×109/L in the last 14 days without blood transfusion; 3) Hemoglobin = 9 g/dL (90 g/L) or = 5.6 mmol/L without blood transfusion or use of erythropoietin in the last 14 days; 4) Total bilirubin = 1.5 × Upper limit of normal value (ULN); Or total bilirubin>ULN but direct bilirubin = ULN; 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 × ULN, or subjects with liver metastasis = 5 × ULN; 6) Blood creatinine = 1.5 × ULN and creatinine clearance (calculated by Cockcroft Gault formula) = 60 ml/min; 7) Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; Or the subject is receiving anticoagulation treatment, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the treatment range of the intended use of anticoagulant; Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) = 1.5 times ULN; Or the subject is receiving anticoagulation treatment, but prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the treatment range of the intended use of anticoagulant; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within normal range. If the baseline TSH is beyond the normal range, the subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; 9) Myocardial zymogram is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality has no clinical significance, it can also be included in the group); h. Sign the written informed consent before implementing any test related process.
Exclusion criteria
Exclusion criteria: a. Having received the following therapies for the tongue cancer: surgical resection, radiotherapy, chemotherapy, targeted therapy and/or immunotherapy; b. Having tumor recurrence or metastasis; c. Have any active malignancy during the last two years, except for cured cancers (such as basal cell carcinoma, superficial bladder cancer, carcinoma in situ of cervix, or breast cancer); d. Receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 14 days before the first administration; e. Poor control of diabetes (FBG>10mmol/L), > class 1 electrolyte disturbance after standard treatment, =class 3 hypoalbuminemia within 14 days before the first administration; f. There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinical active interstitial lung disease; g. Active or uncontrolled infection requiring systemic treatment (including pulmonary tuberculosis); h. History of HIV infection; i. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); j. History of serious hypersensitivity to any other monoclonal antibody; k. Before starting treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention (i.e. = Level 1 or reaching the baseline, excluding fatigue or hair loss); l. Pregnant or lactating women; m. Participating in any other interventional trial simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Rate of the flap transplantation;QLQ-H&N35 quality of life score;2-year overall survival rate; | — |
Countries
China
Contacts
Public ContactMing Song
Sun Yat-Sen University Cancer Center
Outcome results
None listed