Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma
NCT ID: NCT02513342
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2015-03-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endostar+Docetaxel+Cisplatin
Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma , and the Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7.
Endostar
Endostar 30mg continuous intravenous injection pump,d1-d7；
Docetaxel
d4 Docetaxel，75（mg/m2），iv；
Cisplatin
d4，cisplatin，75（mg/m2），iv；
Docetaxel+Cisplatin
Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma.
Docetaxel
d4 Docetaxel，75（mg/m2），iv；
Cisplatin
d4，cisplatin，75（mg/m2），iv；
Interventions
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Endostar
Endostar 30mg continuous intravenous injection pump,d1-d7；
Docetaxel
d4 Docetaxel，75（mg/m2），iv；
Cisplatin
d4，cisplatin，75（mg/m2），iv；
Eligibility Criteria
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Inclusion Criteria
2. According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
3. Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
4. Male or female, age between 18 and 75 years old ;
5. ECOG PS 0\~1；
6. Expected survival period ≥ 3 months or more
7. Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
8. Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); AST and ALT acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
9. Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
10. The electrocardiogram (ecg) basicaly normal,the body had no to heal wounds
11. No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
12. Patients had surgery before,but have more than 4 weeks before the study star, and the patient has recovered;
13. Women with cmpleted uterus before intact in the group within 28 days must have a negative pregnancy test results (unles amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
15. Sign the informed consent.
Exclusion Criteria
2. Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
3. Original serious heart disease, including: congestive heart failure, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
4. With uncontroled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontroled primary brain tumors or CNS metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
5. With a bleeding tendency
6. Researchers believe that patients should not participate in this test.
18 Years
75 Years
ALL
No
Sponsors
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Nanjing NingQi Medicine Science and Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Jinling Hospital
Nanjing, Jiangsu, China
The first affiliated hospital of soochow university
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Yin Qingfeng, Manager
Role: primary
Zhou Xiaolei, Manager
Role: backup
Yin Qingfeng, mananger
Role: primary
Zhou Xiaolei, mananger
Role: backup
Other Identifiers
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JSLCG-001
Identifier Type: -
Identifier Source: org_study_id