Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma

Официальное название

Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study

Обзор

A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.

Вмешательства

• Препарат Nimotuzumab
  Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.
• Препарат Nimotuzumab, Benmelstobart
  Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.
• Лучевая терапия Postoperative Radiotherapy
  Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)

Первичные конечные точки

• Disease-Free Survival (DFS） [Срок оценки: 3-year]

Вторичные конечные точки (4)

• Overall Survival (OS) [Срок оценки: 3-year]
• Adverse Events (AEs) [Срок оценки: 30 days after the last dose (approximately 8 weeks total).]
• Locoregional Recurrence-Free Survival (LRRFS) [Срок оценки: From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled]
• Distant Metastasis-Free Survival (DMFS) [Срок оценки: From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled]

Критерии участия

Критерии включения

• Age ≥ 18 years
• ECOG performance status: 0-2
• Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining)
• Completionof curative-intent surgery, with any of the following intermediate-risk factors present postoperatively:

①pT3-4a;

②N2 disease (excluding cases with extranodal extension);

③Closemargin < 5 mm;

④Lymphovascular and/or perineural invasion;

⑤Invasion depth > 5mm for T2 oral cavity cancer

• Laboratory tests must meet the following criteria:

①Hematologic parameters (within 14 days without transfusion or blood products): a. Hemoglobin (Hb) ≥80 g/L; b.Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; c. Platelet count (PLT) ≥ 80 × 10⁹/L;

②Biochemical parameters: a. Bilirubin (BIL) < 1.5 × upperlimit of normal (ULN); b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;

• Expected survival time ≥ 6 months;
• Women of child bearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use reliable contraception during the study period; Male subjects must use reliable contraception from before treatment initiation until 120 days after the last dose of study drug
• With PD-L1 immunohistochemistry testing
• Participant voluntarily agrees to participate in this study and signs the informed consent form

Критерии исключения

• Pregnancy or lactation, or intention to become pregnant during the study period.
• Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism.
• Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation.
• Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period.
• Diagnosis of another malignancy within 3 years prior to enrollment.
• History of Grade I or higher myocardial ischemia or myocardial infarction, severe arrhythmia, or ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification) within 6 months prior to enrollment.
• Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment.
• Prior treatment of immunotherapy (including PD-1/PD-L1/CTLA-4 antibodies) or anti-EGFR agents.
• Known or suspected allergy to the investigational product or any drug related to this trial.
• Any other severe medical condition that, in the investigator's judgment, may compromise patient safety or interfere with the subject's ability to complete the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07535567 · 2026HN02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗