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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Unknown
Phase 2

Conditions

Nasopharyngeal Cancer
Liver Metastasis
Non Small Cell Lung Cancer

Treatments

Drug: Paclitaxel and Carboplatin
Drug: Paclitaxel , carboplatin, endostatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01347424
XIANSHENG

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Test group
Experimental group
Treatment:
Drug: Paclitaxel , carboplatin, endostatin
control group
Active Comparator group
Treatment:
Drug: Paclitaxel and Carboplatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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