Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma
Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Single-Arm Clinical Trial
Sponsor: Sun Yat-sen University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Complete response rate (CRR)
Time frame: At the end of induction therapy
Secondary Endpoints
Objective response rate (ORR)
Failure-free survival (FFS)
Overall survival (OS)
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 65 years. 2. Histologically confirmed non-keratinizing carcinoma (according to WHO classification). 3. ECOG performance status of 0 or 1. 4. Previously untreated nasopharyngeal carcinoma staged as T3N2M0 or Stage III according to the AJCC 9th edition. 5. Adequate bone marrow function, defined as white blood cell count \> 4×10⁹/L, hemoglobin \> 90 g/L, and platelet count \> 100×10⁹/L. 6. Adequate liver and renal function, defined as total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; and creatinine clearance ≥ 60 mL/min. 7. Normal thyroid function, amylase, lipase, pituitary function, inflammatory markers, myocardial enzymes, and ECG. For patients over 50 years old with a smoking history, pulmonary function test results must be normal. For patients with ECG abnormalities or a cardiovascular history not meeting exclusion criteria #8, echocardiography and cardiac function tests must be normal. 8. Signed info…
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