GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma

Recruiting now · Phase 2

Conditions studied: Nasopharyngeal Carcinoma

In brief

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.

Key facts

Study ID

NCT06455410

Run by

Sun Yat-sen University

People needed

216

Starts

2024-06-18

Expected to finish

2028-06-18

Last updated by the study team

2024-06-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• The second people's hospital of Shenzhen — Shenzhen, China (enrolling)
• 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
• Cancer hospital Chinese academy of medical sciences, Shenzhen center — Shenzhen, China
• The university of Hongkong - Shenzhen hospital — Shenzhen, China
• Foshan First People's Hospital — Foshan, Guangdong, China
• Guangdong Medical School First Affiliated Hospital — Zhangjiang, China

Full record on ClinicalTrials.gov

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