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Recruiting Phase 2 NCT06455410

GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma

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Trial Parameters

Condition Nasopharyngeal Carcinoma
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 216
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-06-18
Completion 2026-06-18
Interventions
GPAdebrelimabconcurrent chemoradiotherapy (CCRT)

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Brief Summary

The purpose of this study is to explore the efficacy and safety of neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients.

Eligibility Criteria

Inclusion Criteria: 1. Patients must be informed of the investigational nature of this study and give written informed consent. 2. Age ≥ 18 years and ≤65 years, men or non-pregnant women. 3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III). 4. Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th). 5. No previous anti-tumor treatment. 6. Eastern Cooperative Oncology Group (ECOG) score 0 or 1. 7. Adequate marrow function: White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) ≤2×upper limit of normal (ULN). 9. Adequate renal function: creatinine clearance rate ≥ 60 ml/min or Creatinine ≤ 1.5× upper limit of normal value. Exclusion Criteria: 1. Patients with recurrent or metastatic nasopharyngeal carcinoma. 2. Histologically confirmed with keratinizing squamous cell carcino

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