Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma (NCT07385079) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma
412 participantsStarted 2026-03-01
Plain-language summary
This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).
Who can participate
Age range18 Years β 65 Years
SexALL
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Inclusion criteria
β. Age β₯18 and β€65 years
β. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
β. Tumor staged as T4N2 and T1-4N3 (AJCC 9th)
β. Eastern Cooperative Oncology Group performance score of 0-11.
β. Adequate marrow function: white blood cell count \> 4 Γ 10βΉ/L hemoglobin \>90g/L and platelet count \>100Γ10βΉ/L
β. Adequate hepatic and renal functionοΌ
β. Other laboratory and clinical criteria
Exclusion criteria
β. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
β. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).
β. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1Γ103 copies/mL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody
β. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.
β. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
β. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
β. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.