Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinomas
- Interventions
- Registration Number
- NCT02611700
- Lead Sponsor
- Biotech Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 504
- Voluntary and sign a consent form;
- Age≥18 years;
- Histological diagnosis as metastatic esophageal squamous cell carcinoma, including: (1)Naked metastatic esophageal cancer：have no opportunity to receive any radical surgery or radical radiation therapy (2) recurrent metastatic esophageal cancer：recurrence after surgery or adjuvant radiotherapy or radical concurrent radio or radiochemotherapy,haven't received systemic chemotherapy and have measurable lesions outside radiotherapy target zone(3) recurrent metastatic esophageal cancer,more than 6 months after neoadjuvant or adjuvant chemotherapy;
- When patients need to receive palliative radiotherapy,the palliative radiotherapy should complete over 4 weeks and target lesions should outside the radiotherapy target zone(radiotherapy lesions include but not limited to primary tumors, bone, lymph nodes);
- According to RECIST 1.1 criteria, at least one measurable lesion exist;
- Expected survival time is over 3 months;
- Eastern Cooperative Oncology Group（ECOG）0 or 1;
- Normal bone marrow and hematopoietic function;total bilirubin acuities≤1.5×Upper Limit Of Normal（ULN）, creatinine≤1.0×ULN, aspartate aminotransferase（AST）/alanine aminotransferase（ALT）≤2.5×ULN, ALP≤5.0×ULN, creatinine clearance > 60 ml/min, liver metastases patients: AST/ALT≤5.0×ULN;
- Take effective contraceptive measures when in growth period;
- Compliance is good.
- Have received any palliative chemotherapy for metastatic esophageal cancer
- Recurrence or metastasis after neoadjuvant chemotherapy or postoperative adjuvant < 6 months;
- Received any kinds of radiotherapy within 4 weeks;
- Patients who can received palliative radiotherapy and all lesions are in one radiation zone;
- Had received adjuvant/neoadjuvant therapy and have used paclitaxel within 6 months;
- Had received adjuvant/neoadjuvant therapy and the cumulative dose of cisplatin was over 300 mg/m2;
- Alone or combined with brain metastasis;
- No measurable tumor lesions;
- Combined with other primary malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ);
- Allergy to the component of investigational drugs;
- Patients who are receiving the treatment of chronic or multiple doses of corticosteroids (inhaled steroids or short-term oral cortisol according to the clinical indications were allowed);
- Haven't recovered to degree 1 from the toxicity of treatment before.
- Concomitant with severe cardiovascular diseases, such as uncontrol heart failure, coronary heart disease, cardiomyopathy, arrhythmia,high blood pressure or history of myocardial infarction within 5 years;
- Concomitant with serious complications, such as the activity of the digestive tract hemorrhage, perforation, severe jaundice, gastrointestinal obstruction, active clinical infection (> 2 levels of infection standard);
- With chronic diarrhea disease and renal insufficiency;
- Have disease affecting cognition or mental abnormal;
- Have other severe acute or chronic diseases;
- Pregnancy or lactation women;
- Have participated in other clinical trials within 30 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group Paclitaxel Nimotuzumab+TP(paclitaxel+cisplatin) control group Placebo Placebo + TP(paclitaxel+cisplatin) experimental group Nimotuzumab Nimotuzumab+TP(paclitaxel+cisplatin) experimental group Cisplatin Nimotuzumab+TP(paclitaxel+cisplatin) control group Paclitaxel Placebo + TP(paclitaxel+cisplatin) control group Cisplatin Placebo + TP(paclitaxel+cisplatin)
- Primary Outcome Measures
Name Time Method Median time of overall survival(OS) Up to 12 months Record all the survival status of each patient and calculate the median OS of all the patients
- Secondary Outcome Measures
Name Time Method Objective response rate（ORR） Up to 12 months 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)%.
Quality of life baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks) 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.
Median time of progression-free survival（PFS） Up to 12 months 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.
Incidence of adverse events Up to 30 days after last administration of nimotuzumab
Trial Locations
- Locations (27)
Chinese PLA General Hospital Medical School of Chinese PLA
🇨🇳Beijing, Beijing, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
AnHui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The 307 Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital
🇨🇳Guangzhou city, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
HuNan Cancer Hospital
🇨🇳Changsha, Hunan, China
Affiliated Hospital ,JiangNan University
🇨🇳Wuxi, Jiangsu, China
JiangSu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
LiaoNing Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
Zhongshan hospital of fudan university
🇨🇳Shanghai, Shanghai, China
The First Affiliated of Xi'an Communication University
🇨🇳Xi'an, Shanxi, China
XiJing Hospital
🇨🇳Xi'an, Shanxi, China
West China Hospital,SiChuan University
🇨🇳Chengdu, Sichuan, China
TianJin Medical University Cancer Institute and Hospital
🇨🇳TianJin, Tianjin, China
Sir Run Run Shaw Hostpital School of Medicine,Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The second Affiliated hospital of Zhejiang University School o
🇨🇳Hangzhou, Zhejiang, China
Zhejiang cancer hospital
🇨🇳Hangzhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China