Esophageal Squamous Cell Carcinoma ResectablePhase 2NCT01688700
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Nimotuzumab combined with paclitaxel and cisplatin in people with Esophageal Squamous Cell Carcinoma Resectable, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma Resectable
- What is being tested?
- Nimotuzumab combined with paclitaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2017
- Phase
- Phase 2
- 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
- Histological or cytologic diagnosis of Esophageal squamous cell carcinoma
- ECOG performance status 0-2
- Age:18-70 years
- Joined the study voluntarily and signed informed consent form
- Patients must not have received any prior anticancer therapy
- Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009）
Show all 10Show fewer
- Target lesions can be measured according to RECIST criteria
- No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
- Use of an effective contraceptive for adults to prevent pregnancy
- Life expectancy of more than 3 months
Who cannot join
- Not suitable to surgery
- cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- early Esophageal Carcinoma(Stage I)
- complete esophageal obstruction，Esophageal perforation or hematemesis
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yun Fan, doctor, 0086-571-88122192, fanyun@csco.org.cn
Weimin Mao, doctor
About this study
Official title: A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity
Read the detailed description
A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases. A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone. The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity.
- Being tested
- Nimotuzumab combined with paclitaxel and cisplatin
- Keywords
- Esophageal Squamous Cell Carcinoma, neoadjuvant therapy, Nimotuzumab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab combined with paclitaxel and cisplatinDrug
Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).
Cisplatin: 75mg/m2,IV on days 1，22
paclitaxel: 90mg/m2, IV on days 1,8,22,29.
patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab plus chemotherapy | Experimental | Not described Receives: Drug: Nimotuzumab combined with paclitaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
Measured: 1 year
Secondary outcomes (5)
R0 resection rate
Measured: 1 year
objective response rate
Objective response rate of neoadjuvant chemotherapy will be assessed.
Measured: 1 year
overall survival
Measured: 5 years
tolerability and safety
number of adverse events such as leucopenia ,rash,diarrhea and so on
Measured: 2 years
Quality of life
Quality of life of patients will be evaluated during and after therapy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2017 (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 Carcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688700
- Sponsor's protocol ID
- NimoESCC
- Status last verified
- Sep 2012
- First submitted
- 16 Sep 2012
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01688700
- Acronym / sponsor ID
- NimoESCC
- Keywords
- Esophageal Squamous Cell Carcinoma, neoadjuvant therapy, Nimotuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 20 Sep 2012 (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.
A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity
Detailed description
A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases. A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone. The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab plus chemotherapy | Experimental | Drug: Nimotuzumab combined with paclitaxel and cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytologic diagnosis of Esophageal squamous cell carcinoma
- ECOG performance status 0-2
- Age:18-70 years
- Joined the study voluntarily and signed informed consent form
- Patients must not have received any prior anticancer therapy
Key exclusion criteria (7 listed)
- Not suitable to surgery
- cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- early Esophageal Carcinoma(Stage I)
- complete esophageal obstruction，Esophageal perforation or hematemesis
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
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 |
|---|---|---|
| Nimotuzumab combined with paclitaxel and cisplatinNimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36). Cisplatin: 75mg/m2,IV on days 1，22 paclitaxel: 90mg/m2, IV on days 1,8,22,29. patients will receive radical operation 4-6 weeks after Neoadjuvant therapy. | Drug | Nimotuzumab plus chemotherapy |
Primary outcome
Pathology complete remission rate
Time frame: 1 year
Pathology complete remission rate is the primary outcome measure.
5 secondary outcomes
R0 resection rate
Time frame: 1 year
objective response rate
Time frame: 1 year
overall survival
Time frame: 5 years
tolerability and safety
Time frame: 2 years
Quality of life
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
Related trials for Esophageal Squamous Cell Carcinoma Resectable
RecruitingPhase 2
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
dCRT vs. Surgery in Resectable ESCC Patients Achieving cCR/PR After Induction Chemoimmunotherapy
Esophageal Cancer
RecruitingPhase 2
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma
Borderline Resectable Carcinoma, Unresectable Cancer
RecruitingPhase 2
Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab combined with paclitaxel and cisplatin in people with Esophageal Squamous Cell Carcinoma Resectable, run by Zhejiang Cancer Hospital at 1 site 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 7 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 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yun Fan, Doctor (0086-571-88122192, fanyun@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology complete remission rate (time frame: 1 year). 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 20 Sep 2012.