Prosthesis SurvivalPhase 3NCT02409186
A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
A Phase 3 study testing Nimotuzumab, radiotherapy and chemoradiotherapy Paclitaxel in people with Prosthesis Survival, run by Shandong Cancer Hospital and Institute at 14 sites in China.
Trial summary
Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- Nimotuzumab, radiotherapy and chemoradiotherapy Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 14 sitesChina
- Study dates
- Mar 2015to Dec 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to study entry
- age：18-70 years
- Histopathology confirmed primary esophageal squamous cell carcinoma, meet one of the following criteria (AJCC Staging System，2009，Seventh Edition):Cervical esophageal carcinoma(stage II-III);upper thoracic esophageal cancer or chest esophageal cancer that is unsuitable or refuse surgery (stage II-III)
- The existence of measurable lesions (according to Response Evaluation Criteria in Solid Tumors 1.1)
- Eastern Cooperative Oncology Group（ECOG）Performance status of 0-1
- Possible semi-liquid diet
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- If there is a risk of pregnancy, male and female subjects must be effective contraception during treatment
- Normal bone marrow reserve: neutrophil (ANC) count≥1500/mm3,platelet count≥100,000 /mm3, hemoglobin≥5.6mmol/L(9g/dL)
- Normal renal function: serum creatinine≤1.5mg/dl and/or calculated creatinine clearance≥ 60ml/min
- Normal hepatic function: bilirubin level≤1.5×ULN, alanine aminotransferase aspartate transaminase（ASAT）\& ALST≤1.5×ULN
- Subjects tumor tissue available for the relevant biomarker detection
Who cannot join
- Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
- Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor（VEGF）therapy or EGFR-pathway targeting therapy not indicated in this study protocol
- Multiple primary carcinomas of the esophagus
- Pregnancy (confirmed by urine β-HCG) or lactation period
- Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
- There are obvious esophageal ulcers, chest and back more than moderate pain, symptoms of esophageal perforation
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- Unable to comprehend the study requirements or who are not likely to comply with the study requirements
- Patients with distant metastasis
- Patients with other malignant disease, except for curable non-melanoma skin cancer, cervical carcinoma in situ or malignant disease cure for≥5 years
- Known grade 3 or 4 allergic reaction to any of the study treatment
- Peripheral neuropathy > grade 1
- Participation in another clinical study within the past 30 days
- Significant disease which, in the investigator's opinion, would exclude the patient from the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Lvhua Wang, 13601283715, wlhwq@yahoo.com
Zongmei Zhou, 13801389769, zhouzongmei2013@163.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Guangying Zhu, 13717999977, zgypu@yahoo.com.cn
Anhui Shi, 13901136511, anhuidoctor@163.com
- Not yet recruiting
The First Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310003
Senxiang Yan, 13957162839, yansenxiang@zju.edu.cn
Haogang Yu, 13516721749, jusn3@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ming Chen, 18758875572, chenming@sysucc.org.cn
Yujin Xu, 13858037993, xuyj@zjcc.org.cn
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Xue Meng, Ph.D, M.D, 86-531-67626142, mengxue5409@126.com
Xue Meng, Ph.D, M.D
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Jun Zhu, 15380882705, zhujdr@126.com
Hong Ji, 18625155033, dr_jihong@163.com
- Not yet recruiting
The Guangxi Zhuang Autonomous Region Cancer Hospita
Nanning, Guangxi, 530021
Xiaodong Zhu, 13978873616, zhuxiaodong83@163.com
Long Chen, 13977129168, clong6@126.com
- Not yet recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Ming Ye, 13901814744, renjiyeming@gmail.com
Xin Xu, 13917978366, 157198711@qq.com
- Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Zhixiong Lin, 13829638278, zxlin5@qq.com
Zhining Yang, 13750443575, 36407342@qq.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 310022
Guang Li, 13804058616, 13804058616@163.com
Jun Dang, 13898150850, dangjunsy@163.com
- Recruiting
Fourth Hospital of Hebei Medical University Tumor
Shijiazhuang, Hebei, 50011
Chun Han, 13831105846, hanchun@yahoo.com.cn
Jun Wang, 13931182128, wangjunzr@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Jianhua Wang, 13938278827, huajianye@sina.cn
Yongshun Chen, 15286831671, yongshun2007@163.com
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212013
Dai Chunhua, PhD, 13952850012
Dai Chunhua, PhD
- Not yet recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, 563099
Hu Ma, 18385034657, mahuab@163.com
Xiaoli Gou, 15121201843, 526392247@qq.com
About this study
Official title: A Randomized, Controlled, Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe and provided statistically significant objective response (47.8%) and disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III trial.
Read the detailed description
The primary endpoint of this study is overall survival, and the primary hypothesis is the experimental arm will improve median survival time (MST) from 18.2 month to 28.5 month. Assuming bilateral ɑ = 0.05, statistical power of 80%.Each group requires a minimum of 59 cases. Consider the 20% loss factor.The total sample size is 200 cases.It is 100 cases in each group.
- Conditions
- Prosthesis Survival
- Being tested
- Nimotuzumab, radiotherapy, chemoradiotherapy Paclitaxel, chemoradiotherapy Cisplatin, placebo
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called Taixinsheng
400mg/w，d1, week 1-7
radiotherapyRadiation
Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
chemoradiotherapy PaclitaxelDrug
Also called Paclitaxel
45 mg/m2, d1, week 1-7
chemoradiotherapy CisplatinDrug
Also called Cisplatin
20 mg/m2, d1, week 1-7
placeboOther
400mg/w，d1, week 1-7
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Active comparator | Nimotuzumab：400mg/w，d1, week 1-7 Paclitaxel：45mg/m2, d1, week 1-7 Cisplatin：20mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7 Receives: Drug: Nimotuzumab; Radiation: radiotherapy; Drug: chemoradiotherapy Paclitaxel; Drug: chemoradiotherapy Cisplatin |
| placebo plus chemoradiotherapy | Placebo comparator | placebo：400mg/w，d1, week 1-7 Paclitaxel：45 mg/m2, d1, week 1-7 Cisplatin：20 mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7 Receives: Radiation: radiotherapy; Drug: chemoradiotherapy Paclitaxel; Drug: chemoradiotherapy Cisplatin; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Over Survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis SurvivalStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- Jinming Yu, Ph.D, M.D, Principal investigator, Shandong Cancer Hospital and InstituteXue Meng, Ph.D, M.D, Study director, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409186
- Sponsor's protocol ID
- NXCEL1311
- Status last verified
- Apr 2016
- First submitted
- 3 Dec 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meng X, Zheng A, Wang J, Wu X, Li G, Zhu J, Ma H, Zhu X, Shi A, Dai C, Yan S, Wang B, Qu Z, Han C, Sun X, Ye M, Fan R, Huerxidan N, Wang X, Yu J. Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial. Br J Cancer. 2023 Nov;129(11):1787-1792. doi: 10.1038/s41416-023-02388-7. Epub 2023 Oct 20.
PubMed 37864049
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02409186
- Acronym / sponsor ID
- NXCEL1311
- Conditions
- Prosthesis Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Apr 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.
Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe and provided statistically significant objective response (47.8%) and disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III trial.
Detailed description
The primary endpoint of this study is overall survival, and the primary hypothesis is the experimental arm will improve median survival time (MST) from 18.2 month to 28.5 month. Assuming bilateral ɑ = 0.05, statistical power of 80%.Each group requires a minimum of 59 cases. Consider the 20% loss factor.The total sample size is 200 cases.It is 100 cases in each group.
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 |
|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Active comparator | Drug: Nimotuzumab, Radiation: radiotherapy, Drug: chemoradiotherapy Paclitaxel, Drug: chemoradiotherapy CisplatinNimotuzumab：400mg/w，d1, week 1-7 Paclitaxel：45mg/m2, d1, week 1-7 Cisplatin：20mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7 |
| placebo plus chemoradiotherapy | Placebo comparator | Radiation: radiotherapy, Drug: chemoradiotherapy Paclitaxel, Drug: chemoradiotherapy Cisplatin, Other: placeboplacebo：400mg/w，d1, week 1-7 Paclitaxel：45 mg/m2, d1, week 1-7 Cisplatin：20 mg/m2, d1, week 1-7 Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent prior to study entry
- age：18-70 years
- Histopathology confirmed primary esophageal squamous cell carcinoma, meet one of the following criteria (AJCC Staging System，2009，Seventh Edition):Cervical esophageal carcinoma(stage II-III);upper thoracic esophageal cancer or chest esophageal cancer that is unsuitable or refuse surgery (stage II-III)
- The existence of measurable lesions (according to Response Evaluation Criteria in Solid Tumors 1.1)
- Eastern Cooperative Oncology Group（ECOG）Performance status of 0-1
Key exclusion criteria (13 listed)
- Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
- Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor（VEGF）therapy or EGFR-pathway targeting therapy not indicated in this study protocol
- Multiple primary carcinomas of the esophagus
- Pregnancy (confirmed by urine β-HCG) or lactation period
- Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
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 |
|---|---|---|
| NimotuzumabAlso: Taixinsheng400mg/w，d1, week 1-7 | Drug | Nimotuzumab plus chemoradiotherapy |
| radiotherapyThree dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7 | Radiation | Nimotuzumab plus chemoradiotherapy, placebo plus chemoradiotherapy |
| chemoradiotherapy PaclitaxelAlso: Paclitaxel45 mg/m2, d1, week 1-7 | Drug | Nimotuzumab plus chemoradiotherapy, placebo plus chemoradiotherapy |
| chemoradiotherapy CisplatinAlso: Cisplatin20 mg/m2, d1, week 1-7 | Drug | Nimotuzumab plus chemoradiotherapy, placebo plus chemoradiotherapy |
| placebo400mg/w，d1, week 1-7 | Other | placebo plus chemoradiotherapy |
Primary outcome
Over Survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 37864049Meng X, Zheng A, Wang J, Wu X, Li G, Zhu J, Ma H, Zhu X, Shi A, Dai C, Yan S, Wang B, Qu Z, Han C, Sun X, Ye M, Fan R, Huerxidan N, Wang X, Yu J. Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial. Br J Cancer. 2023 Nov;129(11):1787-1792. doi: 10.1038/s41416-023-02388-7. Epub 2023 Oct 20.
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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.
Jinming Yu, Ph.D, M.D principal investigator
Shandong Cancer Hospital and Institute
Xue Meng, Ph.D, M.D study director
Shandong Cancer Hospital and Institute
14 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, radiotherapy and chemoradiotherapy Paclitaxel in people with Prosthesis Survival, run by Shandong Cancer Hospital and Institute at 14 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 11 inclusion and 13 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 Jinming Yu, Ph.D, M.D (13806406293, jn7984729@public.jn.sd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Over Survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409186, which also lists 1 linked publication.
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 21 Apr 2016.