Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT02804646 |
Recruitment Status : Unknown
Verified June 2016 by Anhui Provincial Hospital.
Recruitment status was: Recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
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Condition or disease | Intervention/treatment | Phase |
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Adenocarcinoma of Lung | Drug: recombinant human endostatin Drug: pemetrexed plus cisplatin or carboplatin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Recombinant Human Endostatin Durative Transfusion Combined With Pemetrexed Plus Cisplatin or Carboplatin in the First-line Treatment of Advanced Lung Adenocarcinoma With Wild-type EGFR or ALK-negative |
Study Start Date : | June 2016 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: endostar and chemotherapy group
recombinant human endostatin(endostar) injection was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 per one day,every 21 days of a cycle,combined with pemetrexed plus cisplatin or carboplatin.
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Drug: recombinant human endostatin
endostar was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 for one day
Other Name: endostar Drug: pemetrexed plus cisplatin or carboplatin the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
Other Name: pemetrexed disodium |
Active Comparator: chemotherapy group
pemetrexed injection was intravenous with the dose of 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin,without recombinant human endostatin.
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Drug: pemetrexed plus cisplatin or carboplatin
the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
Other Name: pemetrexed disodium |
- progression free survival [ Time Frame: Throughout the study period,an average of 1.5 year ]
- objective response rate [ Time Frame: Throughout the study period,an average of 1.5 year ]
- disease control rate [ Time Frame: Throughout the study period,an average of 1.5 year ]
- overall survival [ Time Frame: after the study finished,an average of 2 year ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) non-small cell lung cancer patients,with wild-type EGFR and ALK-negative; 2) According to IASLC2009 new TNM staging of lung cancer stage ⅢB or Ⅳ, previously untreated or relapsed after 1 year of lung cancer resection; 3) have at least one evaluable lesions,according to version 1.1 of the standard in accordance with a judgment RECIST(longest diameter on a spiral CT at least 10mm,on a regular CT longest diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6) expected survival at least 3 months; 7) adequate hematological function: absolute neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than upper limit of normal (ULN); AST and ALT less than 2.5 times upper limit of normal (ULN); alkaline phosphatase less than 5 times the upper limit of normal (ULN); 9) adequate renal function: serum creatinine less than upper limit of normal (ULN) or calculated creatinine clearance at least 60 mL/min; 10) ECG is normal, there is no non-healing wounds on the body; 11) had not received previous treatment anticancer drugs, or had only received for previous non-metastatic tumors adjuvant or neoadjuvant chemotherapy, but when you start to study treatment has ended more than 6 months; 12) have conducted previous surgery patients required to study treatment was started more than four weeks, and the patient had recovered; 13) have an intact uterus in women prior to enrollment in the study must have a negative pregnancy test result (unless it is already 24 months of amenorrhea) within 28 days. If the pregnancy test from the first administration more than seven days, urine pregnancy test is required for authentication (less than 7 days before the first dose); 14) previous to biological agents, particularly E.coli genetically engineered products without serious allergic reactions; 15) signed informed consent.
Exclusion Criteria:
- 1) pregnancy, breast-feeding women, or female patients of childbearing potential but did not take contraceptive measures;2) existing severe acute infection and is not controlled; or purulent and chronic infection, delayed healing wounds; 3) the original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 4) suffering from neurological and psychiatric diseases or mental disorders is not easy to control, poor compliance, and can not be described with treatment responders; primary brain or central nervous metastasis disease has not been controlled, with significant cranial hypertension or neuropsychiatric symptoms; 5) have bleeding tendencies; 6) other researchers believe that patients should not participate in the present trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804646
Contact: Lejie Cao, professor | sycaolejie@163.com | ||
Contact: Nana Hu | 493305821@qq.com |
China, Anhui | |
Anhui provincial hospital | Recruiting |
Hefei, Anhui, China, 230000 | |
Contact: Lejie Cao, prefessor sycaolejie@163.com | |
Contact: Nana Hu 493305821@qq.com |
Principal Investigator: | Lejie Cao, professor | Anhui Provincial Hospital |
Responsible Party: | Anhui Provincial Hospital |
ClinicalTrials.gov Identifier: | NCT02804646 |
Other Study ID Numbers: |
20160606 |
First Posted: | June 17, 2016 Key Record Dates |
Last Update Posted: | June 21, 2016 |
Last Verified: | June 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Recombinant human endostatin(Endostar) Durative transfusion adenocarcinoma of lung |
Adenocarcinoma Adenocarcinoma of Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Carboplatin Pemetrexed |
Endostatins Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |