Non-small Cell Lung Cancer
Conditions
Brief summary
Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC). Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.
Interventions
DRUGEndostar
7.5mg/m2, D1-14
DRUGVinorelbine
25-30mg/m2, D1,8
DRUGCisplatin
25 mg/m2, D1-3
RADIATIONRadiotherapy
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 treatment. * Allergic to any of the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor blood volume | 3 months |
| Tumor blood flow | 3 months |
| Permeability-surface area product | 3 months |
| 18-FDG PET SUV values | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events | 3 months |
Countries
China
Outcome results
None listed