<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688700</url>
  </required_header>
  <id_info>
    <org_study_id>NimoESCC</org_study_id>
    <nct_id>NCT01688700</nct_id>
  </id_info>
  <brief_title>Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A higher percentage of radical resection is reported in studies using neoadjuvant&#xD;
      chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant&#xD;
      chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a&#xD;
      humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent&#xD;
      trial is a clinical phase II trial designed to assess the efficacy of the combination of&#xD;
      Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with&#xD;
      resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and&#xD;
      toxicity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A surgical resection is currently the preferred treatment for esophageal cancer if the tumor&#xD;
      is considered to be resectable without evidence of distant metastases. A higher percentage of&#xD;
      radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery&#xD;
      versus surgery alone. The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant&#xD;
      chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has&#xD;
      shown effectively. Nimotuzumab is a humanized monoclonal antibody against epidermal growth&#xD;
      factor receptor (EGFR). The clinical phase I study of the combination of Nimotuzumab&#xD;
      administered concurrently with chemo-irradiation in patients with local advanced esophageal&#xD;
      squamous cell carcinoma has shown the safety and the potential efficacy of Nimotuzumab. The&#xD;
      concurrent trial is a clinical phase II trial designed to assess the efficacy of the&#xD;
      combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in&#xD;
      patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its&#xD;
      side-effect and toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathology complete remission rate</measure>
    <time_frame>1 year</time_frame>
    <description>Pathology complete remission rate is the primary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective response rate</measure>
    <time_frame>1 year</time_frame>
    <description>Objective response rate of neoadjuvant chemotherapy will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tolerability and safety</measure>
    <time_frame>2 years</time_frame>
    <description>number of adverse events such as leucopenia ,rash,diarrhea and so on</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>5 years</time_frame>
    <description>Quality of life of patients will be evaluated during and after therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma Resectable</condition>
  <arm_group>
    <arm_group_label>Nimotuzumab plus chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimotuzumab combined with paclitaxel and cisplatin</intervention_name>
    <description>Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).&#xD;
Cisplatin: 75mg/m2,IV on days 1，22&#xD;
paclitaxel: 90mg/m2, IV on days 1,8,22,29.&#xD;
patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.</description>
    <arm_group_label>Nimotuzumab plus chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytologic diagnosis of Esophageal squamous cell carcinoma&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Age:18-70 years&#xD;
&#xD;
          -  Joined the study voluntarily and signed informed consent form&#xD;
&#xD;
          -  Patients must not have received any prior anticancer therapy&#xD;
&#xD;
          -  Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009）&#xD;
&#xD;
          -  Target lesions can be measured according to RECIST criteria&#xD;
&#xD;
          -  No serious system dysfunction and immuno-deficiency, Adequate organ function including&#xD;
             the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet&#xD;
             count ≥100x 109/L, TBIL&lt;1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN&#xD;
&#xD;
          -  Use of an effective contraceptive for adults to prevent pregnancy&#xD;
&#xD;
          -  Life expectancy of more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not suitable to surgery&#xD;
&#xD;
          -  cervical Esophageal Carcinoma(distance of incisor tooth&lt;19cm)&#xD;
&#xD;
          -  early Esophageal Carcinoma(Stage I)&#xD;
&#xD;
          -  complete esophageal obstruction，Esophageal perforation or hematemesis&#xD;
&#xD;
          -  other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in&#xD;
             situ&#xD;
&#xD;
          -  pregnant or breast-feeding women or people during the birth-period who refused to take&#xD;
             contraceptives&#xD;
&#xD;
          -  Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior&#xD;
             11、 History of serious allergic or castor oil allergy 12、 Patients who are not&#xD;
             suitable to participate in the trial according to researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yun Fan, Doctor</last_name>
    <phone>0086-571-88122192</phone>
    <email>fanyun@csco.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yun Fan, doctor</last_name>
      <phone>0086-571-88122192</phone>
      <email>fanyun@csco.org.cn</email>
    </contact>
    <investigator>
      <last_name>Weimin Mao, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Esophageal Squamous Cell Carcinoma</keyword>
  <keyword>neoadjuvant therapy</keyword>
  <keyword>Nimotuzumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Nimotuzumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688700
org study id: NimoESCC
nct id: NCT01688700
lead sponsor: 
has dmc: Yes
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
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathology complete remission rate
time frame: 1 year
description: Pathology complete remission rate is the primary outcome measure.
measure: R0 resection rate
time frame: 1 year
measure: objective response rate
time frame: 1 year
description: Objective response rate of neoadjuvant chemotherapy will be assessed.
measure: overall survival
time frame: 5 years
measure: tolerability and safety
time frame: 2 years
description: number of adverse events such as leucopenia ,rash,diarrhea and so on
measure: Quality of life
time frame: 5 years
description: Quality of life of patients will be evaluated during and after therapy.
arm group label: Nimotuzumab plus chemotherapy
arm group type: Experimental
intervention type: Drug
intervention name: Nimotuzumab combined with paclitaxel and cisplatin
description: 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.
arm group label: Nimotuzumab plus chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yun Fan, Doctor
phone: 0086-571-88122192
email: fanyun@csco.org.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Paclitaxel
mesh term: Nimotuzumab