NCT01347424Unknown2 期
Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The changes of blood flow perfusion in secondary malignant neoplasm of liver
研究概览
简要总结
Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus paclitaxel and carboplatin regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of nasopharyngeal carcinoma or NSCLC
- •With an evaluable secondary malignant neoplasm of Liver, diameter≥2cm
- •Without transcatheter arterial chemoembolization (TACE) treatment
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •Estimated life expectancy of at least 3 months
- •Patient compliance and geographic proximity that allow adequate follow-up.
- •Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) >or= 1.5x10^9/L, platelets >or= 100x10^9/L, hemoglobin >or= 9g/dL. Hepatic: bilirubin <1.5 x ULN, alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x ULN (alkaline phosphatase, AST, ALT < 5 x ULN is acceptable if liver has tumor involvement). Renal: calculated creatinine clearance > 45 ml/min.
- •Men or women of at least 18 years of age.
- •Signed informed consent from patient.
排除标准
- •Women who are pregnant or in lactation
- •Systemic treatment for another cancer within the year prior to study entry
- •Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
- •Severe co-morbidity of any type that may interfere with assessment of the patient for the study
研究组 & 干预措施
Test group
Experimental
干预措施: Paclitaxel , carboplatin, endostatin (Drug)
control group
Active Comparator
干预措施: Paclitaxel and Carboplatin (Drug)
结局指标
主要结局
The changes of blood flow perfusion in secondary malignant neoplasm of liver
时间窗: 12months
次要结局
- Comparing the difference of OS(Overall Survival) and ORR(Objective Response Rate) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the two different arms.(12 months)
- Number of Participants with Adverse Events in the two different arms(12 months)
研究者
Li Zhang
Professor
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic LesionsHepatic DiseaseNCT03652636Indiana University47
Unknown
不适用
Validation of Renal Perfusion CEUS Against MRI, and Its Application in Acute Kidney InjuryKidney Injury, AcutePerfusion ImagingUltrasonographyKidney DiseasesNCT04181281University of Nottingham50
已完成
不适用
Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver DiseaseHepatocellular CarcinomaNCT05772403Fondazione Policlinico Universitario Agostino Gemelli IRCCS100
招募中
不适用
CEUS Improves the Diagnostic Performance of SRSS of Thyroid CarcinomaThyroid NoduleThyroid CarcinomaNCT06146764Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University800
已完成
不适用
Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With CirrhosisLiver CirrhosisNCT03318380Sidney Kimmel Cancer Center at Thomas Jefferson University612