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Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar+Docetaxel+Cisplatin | Experimental | 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. |
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| Docetaxel+Cisplatin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Biological | Endostar 30mg continuous intravenous injection pump,d1-d7; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | FS 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, unknow death , or other anti tumor therapy was used. | up to month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| overall remission rate(ORR) | 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. | |
| Disease control rate (DCR) | 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 | |
|---|---|---|---|---|
| Yin Qingfeng, manager | Contact | 0086-02585632992 | y_qingfeng@163.com | |
| Zhou Xiaolei, sponsor | Contact | 0086-02585566666 | zhouxiaolei@simcere.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | d4 Docetaxel,75(mg/m2),iv; |
|
| Cisplatin | Drug | d4,cisplatin,75(mg/m2),iv; |
|
| Overall survival(OS) | 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. |
| The first affiliated hospital of soochow university | Recruiting | Suzhou | Jiangsu | 215006 | China |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |