β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- PFS ratio in 12 week
研究概览
简要总结
Epidermal Growth Factor Receptor tyrosine-kinase inhibitors （EGFR-TKIs）, including gefitinib，erlotinib and icotinib demonstrate excellent effect on the treatment of non small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance.
详细描述
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib，erlotinib and icotinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Beta-elemene, a natural plant drug extracted from Curcuma wenyujin, has been used as an antitumor drug for different tumors, including NSCLC via mechanism that inhibits Ras/Mapk signaling and cell cycle progression.In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance.
main objectives: progression-free survival (PFS) ratio in 12 week the secondary goal: Objective Response Rate （ORR）
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Obtain of informed consent.
- •Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ⅢB or stage Ⅳ), took EGFR-TKI longer than 6 months and appeared disease progression.
- •At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1).
- •Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-
- •Aged from 18 to 75 years (18 and 75 years are included).
- •Life expectancy ≥12 weeks.
- •Adequate bone marrow reserve and organ function as follows:
- •Absolute neutrophils count (ANC) ≥1.5 x 10 to the 9th power/L (band neutrophil and segmented neutrophil), platelets > 100 x 10 to the 9th power/L and Hb≥90g/L.
- •Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN).
- •Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 times ULN (or less than or equal to 5 times ULN in case of known liver involvement.
- •Renal: Serum Creatinine less than or equal to 1.25 times upper limit of normal (ULN).
- •Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
排除标准
- •Do not meet the above criteria.
- •Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery.
- •Symptomatic Central Nervous System (CNS) metastases.
- •Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA≥500copies or ≥100IU/ml), etc.
- •Prior other malignant disease in 5 years (except carcinoma in situ of cervix, or non melanoma skin cancers, or localized prostate cancer with Gleason ≤6).
- •Take part in new drug clinical trials within one month or taking part in a trial now.
- •Pregnant or lactating woman.
- •Other conditions regimented at investigators' discretion.
研究组 & 干预措施
β-elemene+EGFR TKI
EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) and β-elemene
干预措施: EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) (Drug)
β-elemene+EGFR TKI
EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) and β-elemene
干预措施: β-elemene (Drug)
EGFR TKI
EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)
干预措施: EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) (Drug)
结局指标
主要结局
PFS ratio in 12 week
时间窗: 12 week
progression free survival ratio in 12 week
次要结局
- OR Rate(12 week)
研究者
Yunpeng Liu
Director of Department of Medical Oncology,The First Hospital of China Medical University Affiliation: China Medical University, China
China Medical University, China