Status:
UNKNOWN
The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 fo...
Eligibility Criteria
Inclusion
- primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
- phase IIIB /IV based on IASLC 2009 TNM criteria.
- at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
- male or female, age≥18 or ≤75 years old
- ECOG PS: 0 or 1
- estimated time of survival: ≥ 3 months
- suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
- suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
- suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
- EKG normal
- without no healing wound
- no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment.
- for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment.
- no history of serious allergic to biologic agents, especially E.Coli products
- the authorized ICF must be signed
Exclusion
- Woman in pregnancy and breast-feeding, or having productive ability without contraception.
- Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
- Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
- 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.
- Having the tendency of bleeding, such as FIB\<2G/L
- Being receiving adjuvant chemotherapy.
- On other conditions investigator considers, the subject is not fitful to participate the trial.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02283476
Start Date
November 1 2014
End Date
November 1 2017
Last Update
November 6 2014
Active Locations (1)
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1
Tianjin Cancer Hospital
Tianjin, China, 300060