NCT05940441招募中不适用
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
To explore whether the adjuvant therapy of metronomic capecitabine could improve the disease-free survival of locoregionally advanced hypopharyngeal carcinoma (stage IV：T4N0-1M0，anyTN2-3M0).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old.
- •Histologically confirmed hypopharyngeal carcinoma, staged as IV (T4N0-1M0，anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy ).
- •No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy.
- •Within 8 weeks after completion of the last radiation dose.
- •Performance status of ECOG grade 0 or
- •Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9 /L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase < 2.5×ULN) and renal function (creatinine clearance > 50 ml/min).
- •Patients must be appraised of the investigational nature of the study and provide written informed consent.
排除标准
- •1.Patients who were known to be intolerable or allergic to capecitabine.
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control).
- •With esophagus cancer.
- •Pregnancy or lactation.
- •Other conditions that are not eligible for enrollment.
结局指标
主要结局
disease-free survival
时间窗: 2023.7-2025.7
the time from enrolled to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause
次要结局
未报告次要终点
研究者
研究点 (1)
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