The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment.
详细描述
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment.
main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS（overall survival）
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
- •Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma; According to a new IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer.
- •Must have at least one evaluated lesion,according to the RECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
- •Male or female, age between 18 and 75 years old ;
- •ECOG(Eastern Cooperative Oncology Group) PS (performance status ) 0~1；
- •Expected survival period ≥ 3 months or more
- •Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
- •Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
- •Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
- •The electrocardiogram (ecg) basically normal,the body had no to heal wounds
- •No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
- •Patients had surgery before,but have more than 4 weeks before the study start, and the patient has recovered;
- •Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
- •Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
- •Sign the informed consent.
排除标准
- •Pregnancy, nursing mothers, or female patients with fertility but no contraception.
- •Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
- •Original serious heart disease, including: congestive heart failure, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- •With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(CNS) metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
- •With a bleeding tendency
- •Researchers believe that patients should not participate in this test.
研究组 & 干预措施
Endostar + Gemcitabine and Cisplatin
Patients in this group will be given endostar combined with gemcitabine and cisplatine.
干预措施: Endostar (Drug)
Endostar + Gemcitabine and Cisplatin
Patients in this group will be given endostar combined with gemcitabine and cisplatine.
干预措施: Gemcitabine (Drug)
Endostar + Gemcitabine and Cisplatin
Patients in this group will be given endostar combined with gemcitabine and cisplatine.
干预措施: Cisplatin (Drug)
Gemcitabine and Cisplatin
Patients in this group will be given gemcitabine and cisplatine.
干预措施: Gemcitabine (Drug)
Gemcitabine and Cisplatin
Patients in this group will be given gemcitabine and cisplatine.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Time Frame: up to month 36
PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used.
次要结局
- ORR(Time Frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.)
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