QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1/ CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma:A Randomized, Controlled, Multicenter Phase III Clinical Study.
The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).
• Age ≥18 and ≤65 years
• Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
• Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)
‣ Stage II: T1-3N2
⁃ Stage III: T1-4N3, T4N1-2
• Eastern Cooperative Oncology Group performance score of 0-11.
• Adequate marrow function: white blood cell count \> 4 × 10⁹/Lhemoglobin \>90g/L and platelet count \>100×10⁹/L
• Adequate hepatic and renal function:
‣ Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
⁃ Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN
⁃ Alkaline phosphatase ≤ 2.5 × ULN
⁃ clearance rate ≥ 60 ml/min
• Other laboratory and clinical criteria
‣ Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)
⁃ For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required
⁃ For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits
• Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
• Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).