Lung Cancer
Conditions
Keywords
efficacy and safety
Brief summary
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.
Interventions
DRUGEndostar continuous intravenous infusion
Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
DRUGEndostar routine intravenous infusion
Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total
DRUGGemcitabine
Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total
DRUGCisplatin
Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination. 2. phase IIIB /IV based on IASLC 2009 TNM criteria. 3. at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT ) 4. male or female, age≥18 or ≤75 years old 5. ECOG PS: 0 or 1 6. estimated time of survival: ≥ 3 months 7. suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL 8. suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN. 9. suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min 10. EKG normal 11. without no healing wound 12. no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment. 13. for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment. 14. no history of serious allergic to biologic agents, especially E.Coli products 15. the authorized ICF must be signed
Exclusion criteria
1. Woman in pregnancy and breast-feeding, or having productive ability without contraception. 2. Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound. 3. Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension. 4. Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms. 5. Having the tendency of bleeding, such as FIB\<2G/L 6. Being receiving adjuvant chemotherapy. 7. On other conditions investigator considers, the subject is not fitful to participate the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate based on Recist 1.1 edition | 3 months |
| progress free survival | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 24 months |
| Quality of life (QoL) Questionnaire | 24 months |
Other
| Measure | Time frame |
|---|---|
| biological marker: CECs | 3 months |
Countries
China
Contacts
Primary ContactZhao Yan, Doctor
Outcome results
None listed