Liver Metastasis, Nasopharyngeal Cancer, Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC, NPC
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.
Interventions
DRUGPaclitaxel , carboplatin, endostatin
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of blood flow perfusion in secondary malignant neoplasm of liver | 12months |
Secondary
| 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. | 12 months |
| Number of Participants with Adverse Events in the two different arms | 12 months |
Countries
China
Outcome results
None listed