Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma
An Prospective, Multicenter, Double-blind, Randomized, Controlled Clinical Study of Nimotuzumab Combined With Paclitaxel and Cisplatin as First-line Treatment of Metastatic Esophageal Squamous Cell Carcinomas
1 other identifier
interventional
504
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2015
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 12, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFebruary 1, 2016
January 1, 2016
3.1 years
November 12, 2015
January 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Median time of progression-free survival（PFS）
Up to 12 months
Objective response rate（ORR）
Up to 12 months
Quality of life
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
Study Arms (2)
experimental group
EXPERIMENTALNimotuzumab+TP(paclitaxel+cisplatin)
control group
PLACEBO COMPARATORPlacebo + TP(paclitaxel+cisplatin)
Interventions
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.
400mg,day1,weekly,until disease progression or toxicity
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
AnHui Provincial Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital Medical School of Chinese PLA
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The 307 Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, 510060, China
Cancer Hospital of Shantou University Medical College
Shantou, 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
JiangSu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital ,JiangNan University
Wuxi, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
LiaoNing Cancer Hospital
Shenyang, Liaoning, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan hospital of fudan university
Shanghai, Shanghai Municipality, 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 Municipality, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lin Shen, Dr
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2015
First Posted
November 23, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
February 1, 2016
Record last verified: 2016-01