RecruitingPhase 2NCT06455410
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma
Sponsor
Sun Yat-sen University
Enrollment
216 participants
Start Date
Jun 18, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria9
- 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.
Exclusion Criteria17
- 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.
Interventions
DRUGGP
gemcitabine + cisplatin
DRUGAdebrelimab
a PD-L1 inhibitor
DRUGconcurrent chemoradiotherapy (CCRT)
concurrent chemoradiotherapy (CCRT)
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06455410
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