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Recruiting Phase 2 NCT06349889

Adebrelimab and Chemoradiotherapy in High-risk LANPC

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Trial Parameters

Condition Nasopharyngeal Carcinoma
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-07-23
Completion 2028-05-01
Interventions
Adebrelimab

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Brief Summary

This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).

Eligibility Criteria

Inclusion Criteria: 1. Patients with histologically confirmed nasopharyngeal carcinoma. 2. Tumor staged as IVA+T3N2M0 (AJCC 8th). 3. Eastern Cooperative Oncology Group performance status ≤1. 4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. 5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. 6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula). 7. Patients must be informed of the investigational nature of this study and give written informed consent. 8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug Exclusion Criteria: 1. Ag

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