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| Name | Class |
|---|---|
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
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Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS(overall survival)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar + Gemcitabine and Cisplatin | Experimental | Patients in this group will be given endostar combined with gemcitabine and cisplatine. |
|
| Gemcitabine and Cisplatin | Active Comparator | Patients in this group will be given gemcitabine and cisplatine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Drug | Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used. | Time Frame: up to month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | overall remission rate | Time Frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liu yunpeng, PhD | Contact | 00862483282312 | cmu_trial@163.com | |
| jin bo, PhD | Contact | 00862483282542 | jb_cmu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| liu yunpeng, PhD | First Hospital of China Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25818734 | Background | Wang J, Gu LJ, Fu CX, Cao Z, Chen QY. Endostar combined with chemotherapy compared with chemotherapy alone in the treatment of nonsmall lung carcinoma: A meta-analysis based on Chinese patients. Indian J Cancer. 2014 Mar;51 Suppl 3:e106-9. doi: 10.4103/0019-509X.154099. | |
| 27428214 | Background | Hu W, Fang J, Nie J, Dai L, Zhang J, Chen X, Ma X, Tian G, Wu D, Han S, Han J, Wang Y, Long J. Efficacy and safety of extended use of platinum-based doublet chemotherapy plus endostatin in patients with advanced nonsmall cell lung cancer. Medicine (Baltimore). 2016 Jul;95(28):e4183. doi: 10.1097/MD.0000000000004183. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D043169 | Endostatins |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Shengjing Hospital |
| OTHER |
| General Hospital of Shenyang Military Region | OTHER |
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| Gemcitabine | Drug | Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total |
|
| Cisplatin | Drug | Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total |
|
| 22917490 | Background | Rong B, Yang S, Li W, Zhang W, Ming Z. Systematic review and meta-analysis of Endostar (rh-endostatin) combined with chemotherapy versus chemotherapy alone for treating advanced non-small cell lung cancer. World J Surg Oncol. 2012 Aug 24;10:170. doi: 10.1186/1477-7819-10-170. |
| 26434908 | Result | Zhang FL, Gao EY, Shu RB, Wang H, Zhang Y, Sun P, Li M, Tang W, Jiang BQ, Chen SQ, Cui FB. Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging. Asian Pac J Cancer Prev. 2015;16(15):6765-8. doi: 10.7314/apjcp.2015.16.15.6765. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |