NCT06762327尚未招募2 期
Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- progression-free survival
研究概览
简要总结
In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced/metastatic solid tumors other than primary lung cancer
- •Alk-positive or MET14 exon skipping mutation by IHC\FISH\NGS\RT-PCR
- •Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment
- •Adequate liver and kidney function
- •Adequate bone marrow function
- •ECOG PS 0-3
- •Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided
排除标准
- •Active viral, bacterial, or fungal infection detected 2 weeks before enrollment
- •Pregnancy or lactation
- •receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior)
- •Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)
- •Ineligible cardiac function
- •Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease
- •Lack of adequate bone marrow reserve or organ function
研究组 & 干预措施
Ensartinib
Experimental
干预措施: Ensartinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2 years
time to progression or Intolerable toxicity occurred
Overall responce rate
时间窗: 1year
Proportion of patients with CR/PR response in the total population
次要结局
- Disease control rate(1year)
- Overall survival(3 years)
- Duration of responce(3 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(3 years)
研究者
Xiaowei Wei
Associate chiefphysician
Nanjing First Hospital, Nanjing Medical University
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