Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma

January 29, 2016 updated by: Biotech Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

504

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Bin Hu
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Jing Huang
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chunmei Bai
        • Sub-Investigator:
          • Ning Jia
      • Beijing, Beijing, China
        • Not yet recruiting
        • Chinese PLA General Hospital Medical School of Chinese PLA
        • Principal Investigator:
          • Guanghai Dai
        • Contact:
          • Guanghai Dai
          • Phone Number: 13801232381
        • Contact:
        • Sub-Investigator:
          • Quanli Han
      • Beijing, Beijing, China
        • Not yet recruiting
        • The 307 Hospital of Chinese People's Liberation Army
        • Principal Investigator:
          • Jianming Xu
        • Contact:
          • Jianming Xu
          • Phone Number: 13910866712
        • Contact:
          • Yuling Chen
          • Phone Number: 13871474131
        • Sub-Investigator:
          • Yuling Chen
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Xiaoyan Lin
        • Contact:
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cheng Huang
        • Sub-Investigator:
          • Wu Zhuang
    • Guangdong
      • Guangzhou city, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruihua Xu
        • Sub-Investigator:
          • Dongsheng Zhang
      • Shantou, Guangdong, China
        • Not yet recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
        • Principal Investigator:
          • Yingcheng Lin
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yuxian Bai
        • Contact:
          • Xiaoli Wei
          • Phone Number: 15045449000
        • Sub-Investigator:
          • Xiaoli Wei
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Qingxia Fan
          • Phone Number: 13939039058
        • Contact:
        • Principal Investigator:
          • Qingxia Fan
        • Principal Investigator:
          • Liuxing Wang
        • Sub-Investigator:
          • Wang Ma
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Xianli Yin
          • Phone Number: 13319602869
        • Contact:
        • Principal Investigator:
          • XianliXianli Yin
        • Sub-Investigator:
          • Shaofeng Jiang
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Yongqian Shu
          • Phone Number: 13951017570
        • Contact:
        • Principal Investigator:
          • Yongqian Shu
        • Sub-Investigator:
          • Lianke Liu
      • Wuxi, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital ,JiangNan University
        • Contact:
          • Dong Hua
          • Phone Number: 13093087879
        • Contact:
        • Principal Investigator:
          • Dong Hua
        • Sub-Investigator:
          • Yong Mao
    • Jilin
      • Changchun, Jilin, China
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Cheng
        • Contact:
          • Ying Cheng
          • Phone Number: 13943012851
        • Contact:
        • Sub-Investigator:
          • Yanrong Wang
    • Liaoning
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Tao Sun
          • Phone Number: 18900917877
        • Contact:
        • Sub-Investigator:
          • Xiaoxin Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Changhai Hospital of Shanghai
        • Principal Investigator:
          • Mei WANG
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Qiang Fu
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Jun Zhang
          • Phone Number: 13818332497
        • Contact:
        • Sub-Investigator:
          • Xinfang Shangguan
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Zhongshan Hospital of Fudan University
        • Contact:
          • Tianshu Liu
          • Phone Number: 13681973996
        • Contact:
        • Principal Investigator:
          • Tianshu Liu
        • Sub-Investigator:
          • Yiwei Yu
    • Shanxi
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • The First Affiliated of Xi'an Communication University
        • Contact:
          • Enxiao Li
          • Phone Number: 13992819833
        • Principal Investigator:
          • Enxiao Li
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • Xijing Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xin Wang
        • Sub-Investigator:
          • Li Peng
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital,Sichuan University
        • Contact:
          • Di Lu
          • Phone Number: 13981935716
        • Contact:
        • Principal Investigator:
          • Di Lu
        • Sub-Investigator:
          • Feng Peng
    • Tianjin
      • TianJin, Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Yi Yi
          • Phone Number: 13752157916
        • Contact:
        • Principal Investigator:
          • Yi Yi
        • Sub-Investigator:
          • Jinhuai Xue
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Sir Run Run Shaw Hostpital School of Medicine,Zhejiang University
        • Sub-Investigator:
          • Yu Zheng
        • Principal Investigator:
          • Hongming Pan
        • Contact:
          • Hongming Pan
          • Phone Number: 13605716662
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The second Affiliated hospital of Zhejiang University School o
        • Contact:
          • Ying Yuan
          • Phone Number: 13858193601
        • Contact:
        • Principal Investigator:
          • Ying Yuan
        • Sub-Investigator:
          • Caixia Dong
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Yiping Zhang
        • Contact:
          • Yiping Zhang
          • Phone Number: 13750881678
        • Contact:
        • Sub-Investigator:
          • Guangyuan Lou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntary and sign a consent form;
  2. Age≥18 years;
  3. 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;
  4. 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);
  5. According to RECIST 1.1 criteria, at least one measurable lesion exist;
  6. Expected survival time is over 3 months;
  7. Eastern Cooperative Oncology Group（ECOG）0 or 1;
  8. 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;
  9. Take effective contraceptive measures when in growth period;
  10. Compliance is good.

Exclusion Criteria:

  1. Have received any palliative chemotherapy for metastatic esophageal cancer
  2. Recurrence or metastasis after neoadjuvant chemotherapy or postoperative adjuvant < 6 months;
  3. Received any kinds of radiotherapy within 4 weeks;
  4. Patients who can received palliative radiotherapy and all lesions are in one radiation zone;
  5. Had received adjuvant/neoadjuvant therapy and have used paclitaxel within 6 months;
  6. Had received adjuvant/neoadjuvant therapy and the cumulative dose of cisplatin was over 300 mg/m2;
  7. Alone or combined with brain metastasis;
  8. No measurable tumor lesions;
  9. Combined with other primary malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ);
  10. Allergy to the component of investigational drugs;
  11. 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);
  12. Haven't recovered to degree 1 from the toxicity of treatment before.
  13. 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;
  14. 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);
  15. With chronic diarrhea disease and renal insufficiency;
  16. Have disease affecting cognition or mental abnormal;
  17. Have other severe acute or chronic diseases;
  18. Pregnancy or lactation women;
  19. Have participated in other clinical trials within 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Nimotuzumab+TP(paclitaxel+cisplatin)
Drug: Nimotuzumab
400mg,day1,weekly,until disease progression or toxicity
Drug: Paclitaxel
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.
Other Names:
  • Paclitaxel Injection
Drug: Cisplatin
60mg/m^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Other Names:
  • Cisplatin for Injection
Placebo Comparator: control group
Placebo + TP(paclitaxel+cisplatin)
Drug: Paclitaxel
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.
Other Names:
  • Paclitaxel Injection
Drug: Cisplatin
60mg/m^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Other Names:
  • Cisplatin for Injection
Drug: Placebo
400mg,day1,weekly,until disease progression or toxicity
Other Names:
  • Nimotuzumab Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median time of overall survival(OS)
Time Frame: Up to 12 months
Record all the survival status of each patient and calculate the median OS of all the patients
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median time of progression-free survival（PFS）
Time Frame: 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.
Up to 12 months
Objective response rate（ORR）
Time Frame: 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)%.
Up to 12 months
Quality of life
Time Frame: 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.
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
Up to 30 days after last administration of nimotuzumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Lin Shen, Dr, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPL-IST-ESO-057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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