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Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer

Inclusion Criteria:

- Histologically or cytologically proven inoperable stage IIIb-IV NSCLC

- ECOG PS 0-1

- Life expectancy > 3 months

- Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet
count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL

- Adequate liver function: total bilirubin <1.5 times the upper limit of normal (ULN);
AST and ALT <2.5 times ULN in patients without liver metastases, <5 times ULN in
patients with liver metastases

- Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine
clearance ≥ 50 mL / min and urinary protein <2+. In patients with baseline urinary
protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g

- International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN
within 7 days before enrollment

- Written informed consent

Exclusion Criteria:

- Evidence of bleeding diathesis or coagulopathy

- History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months
before enrollment

- Previously received chemotherapy and radiotherapy and biological targeted therapy

- Uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood
pressure> 100 mm Hg)

- Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular
accident (within 6 months before initiating treatment), myocardial infarction (within
6 months before initiating treatment), unstable angina, congestive heart failure (New
York Heart Association class ≥Grade II) , serious arrhythmia which needs medication
during the study and may affect the study or can not be controlled by drugs

- Unhealed wounds, active peptic ulcer or fracture

- Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months before enrollment

- Women with intact uterus (menopause more than two years excluded) who are unwilling
to take effective non-hormonal contraception (IUD, spermicide barrier birth control
device or sterilization) during the study. Male who are unwilling to take effective
contraceptive measures during the study

- Participated in other clinical trials within 28 days before the initiation of

- Allergic to any of the study drugs

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor blood volume

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Guoliang Jiang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

October 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms