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GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma

RecruitingPhase 2Ages 18 Years - 65 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 carcinoma of the nasopharynx. 3. Prior therapy with radiation or systemic chemotherapy. 4. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 5. Seropositivity for human immunodeficiency virus (HIV). 6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 7. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti- PD-L1, anti-CTLA-4 antibodies. 8. Patients with immunodeficiency disease or a history of organ transplantation. 9. Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks. 10. Patients with severe dysfunction of heart, liver, lung, kidney or marrow. 11. Patients with severe, uncontrolled disease or infections. 12. Received other research drugs or in other clinical trials at the same time. 13. Refuse or fail to sign the informed consent . 14. Patients with other treatment contraindications. 15. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct. 16. Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml or 200 IU/ml. 17. Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative.
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What it tests

  • GP
  • Adebrelimab
  • concurrent chemoradiotherapy (CCRT)
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Where

12 sites
Foshan First People's Hospital
Foshan, China
Affiliated cancer hospital and institute of guangzhou medical university
Guangzhou, China
Sun Yat-Sen Memorial Hospital
Guangzhou, China
The affiliated panyu central hospital of guangzhou medical university
Guangzhou, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, China
Liuzhou Workers Hospital
Liuzhou, China
Guangxi Medical University Affiliated Cancer Hospital
Nanning, China
Cancer hospital of Shantou university medical college
Shantou, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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