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

December 5, 2013 updated by: Li Zhang, Sun Yat-sen University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China
        • SunYat-senU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Drug: Paclitaxel and Carboplatin
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 12 months
12 months
Number of Participants with Adverse Events in the two different arms
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Li Zhang, Cancer Center of Sun Yat-Sen University (CCSU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XIANSHENG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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