NCT06667622招募中2 期
Sodium Glycididazole Reduces Chemoradiotherapy-related Adverse Reactions During Concurrent Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence and severity of grade 3 and above radiation esophagitis
研究概览
简要总结
To evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy.
详细描述
- To evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with sodium glycididazole in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole as a new way to inhibit the occurrence of radiation esophagitis and reduce the occurrence of radiation pneumonitis and lymphopenia.
- To evaluate the sensitization effect of sodium glycididazole in the anti-tumor activity during concurrent chemoradiotherapy, as well as the changes in the anti-tumor immune response in peripheral blood, in order to screen out the dominant population and the predictive biomarkers with fewer related toxic and side effects.
- By exploring the correlation between the expression level of NLRP3 inflammasome activation related molecules and imaging changes in peripheral blood after radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for non-small cell lung cancer was further constructed.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed non-small cell lung cancer.
- •Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy.
- •ECOG PS 0-2
- •Adequate organ and bone marrow function.
排除标准
- •History of previous radiotherapy.
- •The previous immune-related pneumonitis ≥ grade
- •Local lesions require surgery.
- •History of another primary malignancy.
- •History of active primary immunodeficiency.
- •Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
- •For any unmitigated toxicity during pre-study chemoradiotherapy.
研究组 & 干预措施
Sodium glycididazole combined with concurrent chemoradiotherapy group
Experimental
Patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy are treated with sodium glycididazole during concurrent chemoradiotherapy.
干预措施: sodium glycididazole (Drug)
结局指标
主要结局
Incidence and severity of grade 3 and above radiation esophagitis
时间窗: 8 weeks
Radiation esophagitis of grade 3 or higher is graded according to the toxicity criteria of the CTCAE v5.0.
Incidence and severity of grade 2 and above radiation pneumonitis
时间窗: 8 weeks
Radiation pneumonitis of grade 2 or higher is graded according to the toxicity criteria of the CTCAE v5.0.
次要结局
未报告次要终点
研究者
研究点 (1)
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