A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined With Radiotherapy for Elderly Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous cell carcinoma (HNSCC) who are unfit for standard concurrent cisplatin-based chemoradiotherapy. Eligible patients will receive standard-dose intensity-modulated radiotherapy together with weekly nimotuzumab. The primary endpoint is 1-year overall survival rate. Secondary endpoints include progression-free survival, objective tumor response rate, locoregional control rate, distant metastasis rate, and treatment-related adverse events. Patients will be followed up for survival, tumor status and safety assessments after treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years old.
- •Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- •Positive EGFR test result in tumor tissue.
- •Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- •ECOG performance status 0-2 OR KPS score ≥
- •Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.
- •At least one measurable lesion according to RECIST version 1.
- •Estimated life expectancy ≥ 6 months.
- •Adequate hematological function: white blood cell count ≥4×10^9/L; absolute neutrophil count ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90 g/L.
- •Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) >60 mL/min calculated by Cockcroft-Gault formula.
- •Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
- •Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
排除标准
- •Age ≥ 65 years old.
- •Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- •Positive EGFR test result in tumor tissue.
- •Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- •ECOG performance status 0-2 OR KPS score ≥
- •Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.
- •At least one measurable lesion according to RECIST version 1.
- •Estimated life expectancy ≥ 6 months.
- •Adequate hematological function: white blood cell count ≥4×10^9/L; absolute neutrophil count ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90 g/L.
- •Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) >60 mL/min calculated by Cockcroft-Gault formula.
- •Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
- •Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
研究组 & 干预措施
Experimental: Nimotuzumab Combined with Radiotherapy
Patients with locally advanced unresectable head-and-neck squamous cell carcinoma receive definitive intensity-modulated radiotherapy (IMRT) to the primary tumor and regional lymph nodes, concurrently with weekly intravenous nimotuzumab during the radiotherapy course. Tumor response is assessed by RECIST 1.1 and adverse events are graded by CTCAE v5.0.
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal
Percentage of patients achieving complete response (CR) or partial response (PR), assessed according to RECIST version 1.1. Only evaluable patients for tumor response will be included in analysis.
次要结局
- 2-year progression-free survival rate(From start of study treatment up to 24 months)
- 2-year locoregional control rate(From start of study treatment through 2-year follow-up)
- Overall survival(From start of study treatment through 2-year follow-up)
研究者
Ke Hu
Attending Physician
Peking Union Medical College Hospital