Esophageal Squamous Cell CarcinomasPhase 3NCT02611700
Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma
A Phase 3 study testing Nimotuzumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinomas, run by Biotech Pharmaceutical Co., Ltd. at 27 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinomas
- What is being tested?
- Nimotuzumab, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 27 sitesChina
- Study dates
- Nov 2015to Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Ph.D, 13911219511, lin100@medmail.com.cn
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Jing Huang, 13301056087, huangjingwg@163.com
Jing Huang
- Not yet recruiting
Chinese PLA General Hospital Medical School of Chinese PLA
Beijing, Beijing Municipality
Guanghai Dai, 13801232381
Quanli Han, 13366099651, hanquanli@aliyun.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Chunmei Bai, 13511071908, baichunmei@yahoo.com
Ning Jia, 86-010-69158315, jianing@pumch.cn
- Not yet recruiting
The 307 Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
Jianming Xu, 13910866712
Yuling Chen, 13871474131
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin
Ying Cheng, 13943012851
Yanrong Wang, 13944135005, 381299269@qq.com
- Not yet recruiting
HuNan Cancer Hospital
Changsha, Hunan
Xianli Yin, 13319602869
Shaofeng Jiang, 13657356174, luoyi7824@126.com/jsfer@126.com
- Not yet recruiting
West China Hospital,SiChuan University
Chengdu, Sichuan
Di Lu, 13981935716
Feng Peng, 18980601767, pfwork@126.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Cheng Huang, 13905010379, cheng671@sina.com
Wu Zhuang, 13809500871, zhuangwu2008@126.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Xiaoyan Lin, 13950482366, xiaoyanlin@yahoo.com
Xiaoyan Lin
- Recruiting
Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, 510060
Ruihua Xu, Dr, 13922206676, xurh@sysucc.org.cn
Dongsheng Zhang, 13719437860, zhangdsh@sysucc.org.cn
- Not yet recruiting
Sir Run Run Shaw Hostpital School of Medicine,Zhejiang University
Hangzhou, Zhejiang
Hongming Pan, 13605716662
Yu Zheng, 13957179060, ZYubd@hotmail.com
- Not yet recruiting
The second Affiliated hospital of Zhejiang University School o
Hangzhou, Zhejiang
Ying Yuan, 13858193601
Caixia Dong, 15068882349, dcx_1982@163.com
- Not yet recruiting
Zhejiang cancer hospital
Hangzhou, Zhejiang
Yiping Zhang, 13750881678
Guangyuan Lou, 13857108165, louguangyuan@126.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yuxian Bai
Xiaoli Wei, 15045449000
- Not yet recruiting
AnHui Provincial Hospital
Hefei, Anhui
Bin Hu, 13515517331, hubin3756@sina.com
Bin Hu
- Not yet recruiting
JiangSu Province Hospital
Nanjing, Jiangsu
Yongqian Shu, 13951017570
Lianke Liu, 13951623290, liulianke@medmail.com.cn
- Not yet recruiting
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
Mei Wang, 13601810867, wangmeib0211@hotmail.com
Qiang Fu, 13761297128, fumaye66@163.com
- Not yet recruiting
Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality
Jun Zhang, 13818332497
Xinfang Shangguan, 13816860375, clinner_haha@hotmail.com
- Not yet recruiting
Zhongshan hospital of fudan university
Shanghai, Shanghai Municipality
Tianshu Liu, 13681973996
Yiwei Yu, 13816730912, yuyiyi@zs.hospital.sh.cn
- Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong
Yingcheng Lin, 13802715900, linyingcheng@medmail.com.cn
Yingcheng Lin
- Not yet recruiting
LiaoNing Cancer Hospital
Shenyang, Liaoning
Tao Sun, 18900917877
Xiaoxin Wang, 13304001989, wangxiaoxin_1234@163.com
- Not yet recruiting
TianJin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Yi Yi, 13752157916
Jinhuai Xue, 13502065304, xuejh1210@sina.com
- Not yet recruiting
Affiliated Hospital ,JiangNan University
Wuxi, Jiangsu
Dong Hua, 13093087879
Yong Mao, 18651581690, mydoctorw-x@aliyu.com
- Not yet recruiting
The First Affiliated of Xi'an Communication University
Xi’an, Shanxi
Enxiao Li, 13992819833
Enxiao Li
- Not yet recruiting
XiJing Hospital
Xi’an, Shanxi
Xin Wang, 13571826689, wangx@fmmu.edu.cn
Li Peng, 029-84771794, xjyyllwyh@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Qingxia Fan, 13939039058
Wang Ma, 13663846306, doctormawang@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinomas
- Being tested
- Nimotuzumab, Paclitaxel, Cisplatin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
400mg,day1,weekly,until disease progression or toxicity
PaclitaxelDrug
Also called Paclitaxel Injection
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.
CisplatinDrug
Also called Cisplatin for Injection
60mg/m^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
PlaceboDrug
Also called Nimotuzumab Placebo
400mg,day1,weekly,until disease progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Nimotuzumab+TP(paclitaxel+cisplatin) Receives: Drug: Nimotuzumab; Drug: Paclitaxel; Drug: Cisplatin |
| control group | Placebo comparator | Placebo + TP(paclitaxel+cisplatin) Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time of overall survival(OS)
Record all the survival status of each patient and calculate the median OS of all the patients
Measured: Up to 12 months
Secondary outcomes (4)
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.
Measured: 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)%.
Measured: 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.
Measured: baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks)
Incidence of adverse events
Measured: Up to 30 days after last administration of nimotuzumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Dr, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611700
- Sponsor's protocol ID
- BPL-IST-ESO-057
- Status last verified
- Jan 2016
- First submitted
- 12 Nov 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02611700
- Acronym / sponsor ID
- BPL-IST-ESO-057
- Conditions
- Esophageal Squamous Cell Carcinomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Nimotuzumab, Drug: Paclitaxel, Drug: CisplatinNimotuzumab+TP(paclitaxel+cisplatin) |
| control group | Placebo comparator | Drug: Paclitaxel, Drug: Cisplatin, Drug: PlaceboPlacebo + TP(paclitaxel+cisplatin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimotuzumab400mg,day1,weekly,until disease progression or toxicity | Drug | experimental group |
| PaclitaxelAlso: Paclitaxel Injection175mg/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. | Drug | control group, experimental group |
| CisplatinAlso: Cisplatin for Injection60mg/m^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles. | Drug | control group, experimental group |
| PlaceboAlso: Nimotuzumab Placebo400mg,day1,weekly,until disease progression or toxicity | Drug | control group |
Primary outcome
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
4 secondary outcomes
Median time of progression-free survival（PFS）
Time frame: Up to 12 months
Objective response rate（ORR）
Time frame: 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)
Incidence of adverse events
Time frame: Up to 30 days after last administration of nimotuzumab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, Dr study chair
Peking University Cancer Hospital & Institute
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimotuzumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinomas, run by Biotech Pharmaceutical Co., Ltd. at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, Dr (13911219511, lin100@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time of overall survival(OS) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.