MedDataX Logo

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

NCT ID: NCT01347424

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer Nasopharyngeal Cancer Liver Metastasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NSCLC NPC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test group

Group Type EXPERIMENTAL

Paclitaxel , carboplatin, endostatin

Intervention Type DRUG

PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w

control group

Group Type ACTIVE_COMPARATOR

Paclitaxel and Carboplatin

Intervention Type DRUG

PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paclitaxel , carboplatin, endostatin

PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w

Intervention Type DRUG

Paclitaxel and Carboplatin

PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Li Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li Zhang

Role: PRINCIPAL_INVESTIGATOR

Cancer Center of Sun Yat-Sen University (CCSU)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SunYat-senU

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XIANSHENG

Identifier Type: -

Identifier Source: org_study_id