A Phase Ⅳ,Open,Multicenter,Single Arm Study to Evaluate the Efficacy of the Combination Conmana With Thalidomide in Patients With NSCLC(Non-Small-Cell-Lung-Cancer)
试验速览
- 阶段
- 4 期
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- 5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.
研究概览
简要总结
Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI) response rate (ORR), prolong time to progression (PFS), improve patient survival.
详细描述
Primary Objective:
To evaluate the efficacy, survival and side effects of the combined therapy, and to evaluate the effectiveness and safety of thalidomide with Conmana in patients who harbors EGFR mutations.
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
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
- •Patients must have the ability to understand and the willingness to sign a written informed consent document.
- •Patients be age >18 years and < 75 years. Patients must have a Life Expectancy of greater than 3 months.
- •Patients must be NSCLC confirmed by Histological or cytological.
- •Eastern Cooperative Oncology Group (ECOG) score standard: 0-
- •Patients must have normal organ and marrow function as defined below, within two week prior to study: absolute neutrophil count>1,500/mL platelets>100,000/mL total bilirubin: within normal institutional limits Aspartate transaminase (AST)/Alanine aminotransferase (ALT) <2.5 times institutional upper limit of normal creatinine≤1.5 times institutional upper limit of normal urine dipstick for proteinuria of < less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <500mg of protein in 24 hours to allow participation in the study.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Judging by the researchers, that patients can comply with the program.
排除标准
- •Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this study because the agents used in this study may be teratogenic to a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with thalidomide, breastfeeding women are also excluded from this study.
- •During the course of the treatment, the serious active infection of intravenous injection of antibiotics is required.
- •Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide and icotinib or other agents used in the study are excluded.
- •A person who is not effectively controlled, has symptoms of brain metastases, or suffers from a mental disorder that is not easily controlled; has a severe mental or cognitive impairment.
- •Congestive heart failure, arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack in 6 months.
- •5 years of suffering from other malignancies, except for the treatment of cervical carcinoma in situ or skin squamous cell carcinoma of the skin, or the basic control of skin basal cell carcinoma.
- •Can not follow the test program or can not meet the follow-up of patients.
- •The researchers think it is not appropriate to participate in this trial.
研究组 & 干预措施
Conmana and Thalidomide
Conmana(Icotinib Hydrochloride Tablets) and Thalidomide:
Conmana(Icotinib Hydrochloride Tablets) will be administered at 125mg three times a day(TID）continuously; Thalidomide will be administered at 100mg one a day（QD)at night continuously,If can tolerance after 1 weeks to add to 200mg.
干预措施: Conmana (Drug)
Conmana and Thalidomide
Conmana(Icotinib Hydrochloride Tablets) and Thalidomide:
Conmana(Icotinib Hydrochloride Tablets) will be administered at 125mg three times a day(TID）continuously; Thalidomide will be administered at 100mg one a day（QD)at night continuously,If can tolerance after 1 weeks to add to 200mg.
干预措施: Thalidomide (Drug)
结局指标
主要结局
5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.
时间窗: 5 years
次要结局
未报告次要终点
研究者
XiaoJu Zhang
Chief Physician
Henan Provincial People's Hospital