This trial is active, not recruiting.

Conditions non small cell lung cancer, nasopharyngeal cancer, liver metastasis
Treatments paclitaxel , carboplatin, endostatin, paclitaxel and carboplatin
Phase phase 2
Sponsor Sun Yat-sen University
Start date January 2011
End date May 2014
Trial size 40 participants
Trial identifier NCT01347424, XIANSHENG


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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)
paclitaxel and carboplatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w

Primary Outcomes

The changes of blood flow perfusion in secondary malignant neoplasm of liver
time frame: 12months

Secondary Outcomes

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
Number of Participants with Adverse Events in the two different arms
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Principal investigator Li Zhang
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.