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Research purpose:
Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.
1.Research purpose: Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.
2.1 main objectives: PFS 2.2 the secondary goal: 2.2. 1 ORR, DCR and OS 2.2. 2 the quality of life 3. The study design 3.1 research nature This is a single arm, multicenter clinical study, is expected to total 100 patients into the group.
Hierarchical factors include: the tumor staging (Ⅲ B vs Ⅳ), ECOG score (0 v 1), gender (male vs female).
3.2 research center and research Proposed by taizhou people's hospital and medical association of jiangsu province tumor chemotherapy and biological branch of the lung cancer group led by several large and medium-sized hospitals in the province of the malignant tumor treatment related department to participate, in accordance with the unified test plan of this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP(Changchun marina+cisplatin)+Endostar | Experimental | Patients in this group will be given conventional chemotherapy medicine,NP plan (Changchun marina+cisplatin)recommended by treatment guidelines for Advanced non small cell lung cancer. Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles;Changchun marina;25mg/m2,d1 and d8,cisplatin 80mg/m2,d1, q21d×4 |
|
| TP(Taxol+cisplatin or parapl) +Endostar | Experimental | Patients in this group will be given conventional chemotherapy medicine,TP(Taxol+cisplatin)recommended by treatment guidelines for Advanced non small cell lung cancer. Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles; Taxol;135-175mg/m2,d1,cisplatin or parapl 75mg/m2,d1,q21d×4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Biological | Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS(progression-free survival) | PFS is refers to the patients randomly into group to the date of any objective records of patients with tumor progression or death time. | Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective Response Rate) | 1 weeks before treatment, Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase | |
| DCR(disease control rate) | Change from Baseline at the week 6,12, 18 of treatment phase and 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 | 0086-025-85632992 | y_qingfeng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Han gaohua, PI | China:Taizhou people's hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Taizhou People's Hospital | Recruiting | Nanjing | Jiangsu | 225499 | China |
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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 |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Changchun marina | Drug | 25mg/m2,d1 and d8,q21d×4 |
|
| cisplatin | Drug | 80mg/m2,d1, q21d×4 |
|
| Taxol | Drug | 135-175mg/m2,d1,q21d×4 |
|
| parapl | Drug | AUC=5-6,d1,q21d×4 |
|
| OS(overall survival) | Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |