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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar continuous intravenous infusion | Experimental | Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Drug | continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate based on Recist 1.1 edition | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progress free survival | 8 weeks |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle |
|
| Carboplatin | Drug | carboplatin is administered on Day 1 of each 21-day,followed by docetaxol or pemetrexed |
|
| Pemetrexed | Drug | pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |