Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion criteria:
Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;
Phase IIIB/IV based on TNM criteria (8th);
At least one measurable tumor based on RECIST 1.1;
Without the known active mutation of EGFR/ALK/ROS1/RET;
Male or female, age≥18 or ≤70 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 healing wound;
No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;
For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;
No history of serious allergic to biologic agents, especially E.Coli products;
The authorized ICF must be signed.
Exclusion Criteria:
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.
Sites / Locations
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin