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Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non Small Cell Lung Cancer, Nasopharyngeal Cancer, Liver Metastasis

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Trial Information


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The changes of blood flow perfusion in secondary malignant neoplasm of liver

Outcome Time Frame:

12months

Safety Issue:

No

Principal Investigator

Li Zhang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center of Sun Yat-Sen University (CCSU)

Authority:

China: Food and Drug Administration

Study ID:

XIANSHENG

NCT ID:

NCT01347424

Start Date:

January 2011

Completion Date:

June 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Nasopharyngeal Cancer
  • Liver Metastasis
  • NSCLC
  • NPC
  • Carcinoma, Non-Small-Cell Lung
  • Liver Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Nasopharyngeal Neoplasms

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