NCT07744074招募中不适用
A Single-Arm Phase I Clinical Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Malignant Tumors
Ji Yongling1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicities
研究概览
简要总结
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 old;
- •Pathologically confirmed thoracic solid malignant tumors;
- •Local recurrence or failure of prior standard therapies (including surgery, radiotherapy, systemic therapy, etc.), deemed unsuitable for or lacking standard treatment options following Multidisciplinary Team (MDT) evaluation, and planned to receive heavy-ion radiotherapy；
- •Maximum diameter of the target lesion ≥ 4.5 cm;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Life expectancy ≥ 6 months;
- •Signed informed consent.
排除标准
- •Tumors adjacent to critical organs at risk (OARs) where dose constraints cannot be met through plan optimization;
- •Prior radiotherapy to the intended treatment area, where re-irradiation would fail to meet normal tissue dose constraints;
- •Presence of recognized standard treatment options for which the patient is eligible (e.g., radical surgery, concurrent chemoradiotherapy, or standard systemic therapy);
- •Primary hematologic malignancies;
- •Uncontrolled severe comorbidities, including active infections, unstable cardiovascular or cerebrovascular diseases, and severe hepatic or renal insufficiency;
- •Other diseases deemed by the investigator to compromise patient safety;
- •Psychiatric disorders or cognitive impairment that would prevent cooperation with treatment;
- •Pregnancy or lactation.
结局指标
主要结局
Dose-Limiting Toxicities
时间窗: 90 days
To determine the dose-limiting toxicities (DLTs) of carbon ion - lattice radiotherapy (CI-LRT) in this population.
次要结局
未报告次要终点
研究者
Ji Yongling
PI
Zhejiang Cancer Hospital
研究点 (1)
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