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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 386
- 主要终点
- Disease-Free Survival (DFS）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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.
研究组 & 干预措施
IMRT-Nimotuzumab + Benmelstobart
Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy
干预措施: Nimotuzumab, Benmelstobart (Drug)
IMRT-Nimotuzumab + Benmelstobart
Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy
干预措施: Postoperative Radiotherapy (Radiation)
IMRT-Nimotuzumab
Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT)
干预措施: Postoperative Radiotherapy (Radiation)
IMRT-Nimotuzumab
Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT)
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Disease-Free Survival (DFS）
时间窗: 3-year
From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause
次要结局
- Overall Survival (OS)(3-year)
- Adverse Events (AEs)(30 days after the last dose (approximately 8 weeks total).)
- Locoregional Recurrence-Free Survival (LRRFS)(From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled)
- Distant Metastasis-Free Survival (DMFS)(From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled)
研究者
Guopei Zhu
Principal Investigator, Clinical Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University