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This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatin(TP) compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.
This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with TP compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.The main endpoint is OS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Nimotuzumab+TP(paclitaxel+cisplatin) |
|
| control group | Placebo Comparator | Placebo + TP(paclitaxel+cisplatin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | 400mg,day1,weekly,until disease progression or toxicity |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median time of overall survival(OS) | Record all the survival status of each patient and calculate the median OS of all the patients | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median time of progression-free survival(PFS) | PFS is the time that passes from the date of signing Informed Consent Form(ICF)to the data on which "progresses" or the date on which the patient dies from any cause. The definition of "progression" since this generally involves imaging techniques(CT,MRI,et al).The Response Evaluation Criteria In Solid Tumors (RECISIT) 1.1 criteria will be used to evaluate "progression".The imaging evaluation will be done every 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, Dr | Contact | 13911219511 | lin100@medmail.com.cn | |
| Jun Zhou | Contact | 13366152815 | 13366152815@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, Dr | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnHui Provincial Hospital | Not yet recruiting | Hefei | Anhui | China |
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| Paclitaxel |
| Drug |
175mg/m^2,for 3 hour(Peripherally Inserted Central Catheter,PICC),day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles. |
|
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| Cisplatin | Drug | 60mg/m^2,day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles. |
|
|
| Placebo | Drug | 400mg,day1,weekly,until disease progression or toxicity |
|
|
| Up to 12 months |
| Objective response rate(ORR) | This wil be evaluated by RECISIT 1.1 criteria.It is dependent on imaging evaluation which will be done every 6 weeks. ORR is the percent of the patient who is evaluated as complete response(CR) or partial response (PR),that is (CR+PR)%. | Up to 12 months |
| Quality of life | Using the European Organization for Research and Treatment of Cancer(EORTC)quality of life questionnaire(QLQ)-C30(Version3.0)and EORTC QLQ - OES18 to evaluate the quality of life of patients. The patients will fill this questionnaire when signing the ICF(as baseline) and every 6 weeks during treatment,until disease progression,up to 52 weeks. The progression is from date of randomization until the date of first documented progression or date of death from any cause. | baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks) |
| Incidence of adverse events | Up to 30 days after last administration of nimotuzumab |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
|
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Chinese PLA General Hospital Medical School of Chinese PLA | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The 307 Hospital of Chinese People's Liberation Army | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Cancer Hospital of Shantou University Medical College | Not yet recruiting | Shantou | Guangdong | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
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| HuNan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
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| JiangSu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| Affiliated Hospital ,JiangNan University | Not yet recruiting | Wuxi | Jiangsu | China |
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| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | China |
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| LiaoNing Cancer Hospital | Not yet recruiting | Shenyang | Liaoning | China |
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| Changhai Hospital of Shanghai | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Zhongshan hospital of fudan university | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| The First Affiliated of Xi'an Communication University | Not yet recruiting | Xi’an | Shanxi | China |
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| XiJing Hospital | Not yet recruiting | Xi’an | Shanxi | China |
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| West China Hospital,SiChuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| TianJin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Sir Run Run Shaw Hostpital School of Medicine,Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The second Affiliated hospital of Zhejiang University School o | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang cancer hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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