The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective response rates (ORR)
研究概览
简要总结
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance. The purpose of this study is to investigate the efficacy and drug resistance mechanism of Apatinib combine with EGFR-TK1 treated for advanced slow progressed non-small cell lung cancer and provide new treatment options.
详细描述
Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Previous studies demonstrated that the anti-angiogenesis combined with EGFR-TKI in slow-progressed EGFR mutation-positive non-small cell lung cancer achieved good efficacy and disease control rates, prolonged the progression free survival. The present study is aim to expand the number of samples to monitor resistance-related genes and tumor cells. Furthermore, to investigate the mechanism of anti-angiogenesis combine with EGFR-TKI and provide the theory for the use and promotion of clinically protocols. In this study, the primary objective is the objective response rates and the secondary goal are disease control rates, overall survival, progression free survival and drug safety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent should be obtained before treatment. Patients with good compliance.
- •Histologically or cytologically confirmed IIIB/IV NSCLC.
- •Progress in the treatment of EGFR TKI.
- •Aged from 18 to 75 years (18 and 75 years are included); Gender Not Required.
- •Life expectancy ≥ 3 months.
- •At least one measurable lesion (meet the requirements of the standard Response Evaluation Criteria In Solid Tumors (RESCIST) version 1.1). If the lesions that have received local treatment (radiation, radiofrequency, intervention, etc.) are the only lesions, it is required to have clear imaging progress.
排除标准
- •Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment); Poor control of blood sugar.
- •Acute phase of cerebral infarction, or recovery period <2 months.
- •A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.)
- •Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) a history of melena and hematemesis within 2 months. Simple fecal occult blood (+) is not an exclusion criterion.
- •Coagulation abnormality (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency.
- •Urine protein ≥ ++ or confirmed 24-hour urine protein quantitation > 1.0 g.
- •Pregnant or lactating women.
- •Severe liver and kidney dysfunction (grade 4) .
- •Allergic to any ingredient of apatinib mesylate.
- •A history of abuse of psychotropic substances and are unable to quit smoking or mental disorders.
- •According to the investigator's judgment, people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
- •Surgery, major trauma or fracture, within 4 weeks before the treatment or unhealed wound before treatment.
- •Severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, grade III or above (CCS standard) angina, a history of myocardial infarction within 6 months before the treatment, or medication treated arrhythmia.
- •Brain metastasis and meningeal metastasis.
研究组 & 干预措施
Apatinib combined with EGFR-TKI
Apatinib 250 millgram（mg/day（d））combined with EGFR-TKI
干预措施: Apatinib（250mg/d） combined with EGFR-TKI (Drug)
结局指标
主要结局
Objective response rates (ORR)
时间窗: two years
Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）
次要结局
- Progression free survival (PFS)(two years)
- Disease control rate (DCR)(two years)
- Overall survival (OS)(two years)
- Drug safety: Number of participants with treatment-related adverse events(two years)
研究者
Liyan Xu
Chief of Medical Oncology Department
Beijing Chest Hospital