NCT01564329Unknown2 期
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the change of blood perfusion before/after the use of Endostar
研究概览
简要总结
To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically newly diagnosed as unresectable and metastasis advanced lung adenocarcinoma(Stage IV, Seventh Edition of the UICC/AJCC Classification for Lung Cancer).
- •At least one measurable objective tumor lesion, spiral CT or PET-CT examination: the shortest diameter ≥2cm，and no obvious necrosis
- •Life expectancy ≥12weeks
- •Patients receive palliative radiotherapy for bone's pain relief; patients receive radiotherapy for brain metastasis、patients after brain transfer operation or radiation therapy are allowed to enter the research.
- •18≤Patients'age <70 years.
- •Electrocolonogram (ECOG) Score:0-
- •Granulocyte count ≥ 2.0×109/L, platelet count ≥ 100×109/L.
- •Serum bilirubin within the normal range.
- •Aspartate aminotransferase ( AST ), Alanine aminotransferase ( ALT ) within the normal range(if the patients is diagonosed as liver metastasis,his/her AST/ALT should not surpass 1.5 times of the normal range ).
- •Serum creatinine within the normal range and creatinine clearance rate ≥60ml/min
- •Compliance with research requirements and be able to follow up.
- •Within 72 hours before the treatment, all women pregnant with pregnant possibility should undergo pregnancy test and get negative results.
- •Patients with fertility ability should take effective contraceptive techniques.
- •Sign informed consent of this clinic trial.
排除标准
- •Lung adenocarcinoma patients who received systemic chemotherapy/thoracic radiotherapy/targeted therapy
- •Received resection, cutting or aspiration within seven days
- •Any unstable systemic diseases (including peptic ulcer、active infection、grade4 hypertension、unstable angina、congestive heart failure、liver, metabolic disorders or fracture、unhealing wound )
- •Chronic kidney disease history(including chronic nephritis, nephrotic syndrome, Obstruction of urinary tract etc. caused by Urinary calculus)
- •have to use anticoagulant drugs at the same time
- •patients with obvious coagulation disorders、active bleeding and bleeding tendency
- •Any other malignancies (complete cure of cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma are excluded )happened within 5 years.
- •Signifinant weight loss, weight lost during the 6 weeks more than or equal to 10%
- •Patients who take bone metastasis as the only observing index
- •Allergic to escherichia coli preparation
- •Used Endostar before
- •Lactating women
- •Contraindications written on Pemetrexed、Carboplatin、Dexamethasone instructions
- •Allergic to radiographic contrast agents
- •In the middle or planning to attend other clinic trails
研究组 & 干预措施
endostar2
Experimental
CT Perfusion Imaging(CTPI) at D0, D21 of the first cycle、D6, D14 of the second cycle, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment.
干预措施: endostar (Drug)
endostar1
Experimental
CT Perfusion Imaging(CTPI) at D0，D6, D14, D21 of the first period, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment.
干预措施: endostar (Drug)
结局指标
主要结局
the change of blood perfusion before/after the use of Endostar
时间窗: per 3 weeks
次要结局
- tumor to progress(6 months)
- clinical benefit rate(per 6 weeks)
- Adverse Drug Reaction(per 1 day)
研究者
研究点 (1)
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