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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347424
Recruitment Status : Unknown
Verified November 2010 by Li Zhang, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2011
Last Update Posted : December 9, 2013
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Nasopharyngeal Cancer Liver Metastasis Drug: Paclitaxel , carboplatin, endostatin Drug: Paclitaxel and Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test group Drug: Paclitaxel , carboplatin, endostatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w endostatin:7.5 mg/m2 iv 3-4h, d1~15,q3w
Active Comparator: control group Drug: Paclitaxel and Carboplatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w

Primary Outcome Measures :
  1. The changes of blood flow perfusion in secondary malignant neoplasm of liver [ Time Frame: 12months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
  2. Number of Participants with Adverse Events in the two different arms [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347424

China, Guangdong
GuangZhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Li Zhang Cancer Center of Sun Yat-Sen University (CCSU)

Responsible Party: Li Zhang, Professor, Sun Yat-sen University Identifier: NCT01347424     History of Changes
Other Study ID Numbers: XIANSHENG
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: November 2010

Keywords provided by Li Zhang, Sun Yat-sen University:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Nasopharyngeal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents