Oral Squamous Cell Carcinoma:
Conditions
Interventions
Experimental group:QL1706, 5 mg/kg, iv, Q3W
Albumin-bound paclitaxel, 260 mg/m2, iv, Q3W
Cisplatin, 75 mg/m2, iv, Q3W
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 and = 9.0 g/dL (may be maintained by transfusion). * Absolute Neutrophil Count (ANC) >= 1.0 × 10?/L. * Platelet count >= 100 × 10?/L. * Total bilirubin = Upper Limit of Normal (ULN). * Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) = 60 mL/min. * For patients not on therapeutic anticoagulation: International Normalized Ratio (INR) <= 1.5 and Activated Partial Thromboplastin Time (aPTT) <= 1.5 × ULN. Patients on stable, full-dose anticoagulant therapy for at least 2 weeks prior to study entry are eligible provided coagulation parameters are within the therapeutic range. 11. For women of childbearing potential (WOCBP): A negative urine or serum pregnancy test within 3 days prior to the first dose of study drug (serum test prevails if urine test is inconclusive). WOCBP must agree to use a highly effective method of contraception from screening and continue its use for at least 120 days after the last dose of the study drug. Periodic abstinence and the calendar method are not acceptable. 12. Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Prior anticancer therapy for the current oral cancer (including but not limited to surgery, radiotherapy, cytotoxic drugs, targeted therapy, or investigational agents). 2. Pathological confirmation of a non-squamous cell carcinoma histology (e.g., adenocarcinoma, mucoepidermoid carcinoma). 3. History of another active malignancy within the past 5 years, except for appropriately treated carcinoma in situ, early-stage tumors (e.g., Stage I skin basal cell or squamous cell carcinoma, thyroid cancer), or cervical carcinoma in situ. 4. Treatment with any investigational drug within 28 days prior to randomization, or concurrent participation in another clinical trial. 5. Active, known, or suspected autoimmune disease. 6. Radiologically or pathologically confirmed central nervous system metastases, leptomeningeal disease, or spinal cord compression. 7. Clinically significant effusions (pleural, pericardial, or ascitic) requiring therapeutic intervention or repeated drainage. 8. Major bleeding events within 3 months prior to the first dose (requiring transfusion, intervention, or hospitalization), current bleeding requiring intervention, or high-risk bleeding conditions as judged by the investigator. 9. Clinical evidence of esophageal/bronchial or esophageal/aortic fistula within 6 months prior to the first dose. 10. Evidence of complete esophageal obstruction not amenable to treatment. 11. Child-Pugh class B or C cirrhosis. 12. Continuous use of non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulants within 7 days prior to the first dose. (Patients on stable, therapeutic anticoagulation may be eligible per inclusion criterion #10). 13. Major surgical procedure, significant trauma, or unhealed/unhealing wounds within 4 weeks prior to the first dose. 14. Significant cardiovascular or cerebrovascular disease, including: * Myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute/persistent myocardial ischemia, or symptomatic heart failure (NYHA Class =II) within 6 months prior to the first dose. * Symptomatic or poorly controlled arrhythmia. * Arterial thromboembolic event within 6 months prior to the first dose. * History of deep vein thrombosis, pulmonary embolism, or other severe thromboembolism within 3 months prior to the first dose. * Life-threatening major vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic carotid stenosis) requiring surgical intervention within 6 months. * Uncontrolled hypertension despite standard therapy. * History of hypertensive crisis or hypertensive encephalopathy. * History of myocarditis or cardiomyopathy. * Left ventricular ejection fraction (LVEF) 500 IU/mL or > 2500 copies/mL) or active hepatitis C. (Asymptomat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response (MPR);Negative rate for minimal Residual Disease (MRD);Objective Response Rate (ORR);TRAEs; | — |
Countries
China
Contacts
Public ContactRixiong Wang
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed