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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
504
400mg,day1,weekly,until disease progression or toxicity
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.
60mg/m\^2,day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Median time of overall survival(OS)
Record all the survival status of each patient and calculate the median OS of all the patients
Time frame: Up to 12 months
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.
Time frame: 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)%.
Time frame: 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.
Time frame: baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks)
Incidence of adverse events
Time frame: Up to 30 days after last administration of nimotuzumab
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400mg,day1,weekly,until disease progression or toxicity
AnHui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChinese PLA General Hospital Medical School of Chinese PLA
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe 307 Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGSun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, China
RECRUITINGCancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
NOT_YET_RECRUITING...and 17 more locations