Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Evaluation consistency
研究概览
简要总结
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.
详细描述
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •NSCLC patients with stage IIIB-IV
- •Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);
- •First line targeted therapy.
- •Performance status of 0-2 on the ECOG criteria.
- •Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA>15ng/ml,CA-199>105U/ml,CA-125>105 U/ml, NSE>60 ng/ml, SCCAg>7.5 ng/ml, CYFRA21-1>21 ng/ml, et al.
- •Measurable lesions present
- •Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 60,000/uL,hemoglobin≥70g/L), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function.
- •Informed consent from patient or patient's relative.
排除标准
- •Patients with dysphagia;
- •Unable to taking medication on time;
- •Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders
结局指标
主要结局
Evaluation consistency
时间窗: efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year
The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.
次要结局
- progression-free survival （PFS）(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Xueqin Yang
Prof.
Third Military Medical University