Brief Title
Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The changes of blood flow perfusion in secondary malignant neoplasm of liver
Secondary Outcome
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.
Condition
Non Small Cell Lung Cancer
Intervention
Paclitaxel , carboplatin, endostatin
Study Arms / Comparison Groups
Test group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
January 2011
Completion Date
October 2014
Primary Completion Date
May 2014
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: - 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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Li Zhang, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01347424
Organization ID
XIANSHENG
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Li Zhang, Principal Investigator, Cancer Center of Sun Yat-Sen University (CCSU)
Verification Date
November 2010