Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography

Study Overview
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Brief Summary
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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.

Conditions
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Non Small Cell Lung Cancer, Nasopharyngeal Cancer, Liver Metastasis

Intervention / Treatment
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* Drug: Paclitaxel , carboplatin, endostatin
* Drug: Paclitaxel and Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Drug: Paclitaxel , carboplatin, endostatin<br>* PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w<br>|
| Active Comparator: control group<br> | Drug: Paclitaxel and Carboplatin<br>* PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of blood flow perfusion in secondary malignant neoplasm of liver |  | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, NPC