<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/NCT03817567</url>
  </required_header>
  <id_info>
    <org_study_id>SCT200IbmESCC</org_study_id>
    <nct_id>NCT03817567</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>Phase Ib, Open-label, Single-arm, Multicenter Study to Evaluate Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma Progressed Following Treatment With Taxane/Platinum/Fluorouracil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinocelltech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sinocelltech Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR&#xD;
      monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma&#xD;
      progressed following treatment with taxane/platinum/fluorouracil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a open label, single-arm multicenter phase Ib study,and is designed to evaluate&#xD;
      Objective Response Rate (ORR) in advanced esophageal squamous cell carcinoma progressed&#xD;
      following treatment with taxane/platinum/fluorouracil treated with anti-EGFR monoclonal&#xD;
      antibody SCT200.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 17, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</primary_completion_date>
  <phase>Phase 1/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>Objective response rate (ORR)</measure>
    <time_frame>one year</time_frame>
    <description>ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>one year</time_frame>
    <description>AE are assessed according to NCI CTCAE v4.03.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>one year</time_frame>
    <description>PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>one year</time_frame>
    <description>DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>one year</time_frame>
    <description>OS is defined as time from first dose of SCT200 until the date of death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>recombinant anti-EGFR monoclonal antibody（SCT200）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6.0mg/kg QW for 6 weeks, then 8.0mg/kg Q2W</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant anti-EGFR monoclonal antibody</intervention_name>
    <description>Experimental: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.</description>
    <arm_group_label>recombinant anti-EGFR monoclonal antibody（SCT200）</arm_group_label>
    <other_name>SCT200</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females. Aged 18 to 75 years old;&#xD;
&#xD;
          -  Histologically or cytologically proven squamous cell carcinoma of the esophagus, which&#xD;
             is locally unresectable or distant metastatic disease;&#xD;
&#xD;
          -  Disease progressed following standard therapies. Patients has treated with&#xD;
             taxane/platinum/fluorouracil and/or radiotherapy. Failure of standard therapy ：Disease&#xD;
             progressed or developed non-tolerable toxicity during or within 3 months after last&#xD;
             systemic chemotherapy or radical concurrent chemoradiotherapy. For adjuvant&#xD;
             therapy/neoadjuvant therapy, disease relapse or progression during treatment or within&#xD;
             6 months after treatment is considered as failure of standard therapy;&#xD;
&#xD;
          -  According to RECIST 1.1 , patients must have at least one measurable lesion which was&#xD;
             not treated with local treatment such as radiotherapy. Tumour lesions situated in a&#xD;
             previously irradiated area which have been demonstrated progression in the lesion, are&#xD;
             considered measurable;&#xD;
&#xD;
          -  With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1;&#xD;
&#xD;
          -  Life expectancy of longer than 3 months ( clinical assessment);&#xD;
&#xD;
          -  Adequate organ and marrow function as defined below:&#xD;
&#xD;
        Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater&#xD;
        than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase&#xD;
        (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to&#xD;
        5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within&#xD;
        institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN;&#xD;
        Electrolyte: magnesium greater than/equal to normal.&#xD;
&#xD;
          -  Women of childbearing potential must not be pregnant as assessed by a negative urine&#xD;
             or serum beta HCG test upon admission to the hospital, and must agree to use adequate&#xD;
             contraception during the study until to 6 months after the last dose of SCT200.For&#xD;
             male,if his sexual partners is child-bearing potential, he should use effective&#xD;
             contraception from the time of signing the informed consent form until at least 6&#xD;
             months after the last dose of study drug.&#xD;
&#xD;
          -  Able to provide written informed consent and can understand and comply with the&#xD;
             requirements of the study;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active central nervous system metastasis or a history of central nervous&#xD;
             system metastasis;(If the subject has been suspected with central nervous system&#xD;
             metastasis,imaging examination confirmation must be performed within 28 days to&#xD;
             exclude central nervous system metastasis;&#xD;
&#xD;
          -  Patients with other primary malignancies except cured of non-melanoma skin cancer,&#xD;
             carcinoma in situ of cervix or prostatic intraepithelial neoplasia;&#xD;
&#xD;
          -  Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;&#xD;
&#xD;
          -  Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR&#xD;
             monoclonal antibody;&#xD;
&#xD;
          -  Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone&#xD;
             therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or&#xD;
             patients with grade 2 or more adverse reaction caused by previous anti-tumor&#xD;
             therapy(except alopecia or neurotoxicity grade 2 or less);&#xD;
&#xD;
          -  Patients are currently enrolled in other research devices or in research drugs, or&#xD;
             less than 4 weeks from other research drugs or devices;&#xD;
&#xD;
          -  Patients received major surgery(such as need general anesthesia ) within 4 weeks ,&#xD;
             should recover from the injury associated with the surgery;&#xD;
&#xD;
          -  Patients treated with EPO, G-CSF or GM-CSF;&#xD;
&#xD;
          -  Patients who have clinically significant cardiovascular disease (defined as unstable&#xD;
             angina pectoris, symptomatic congestive heart failure (NYHA, greater than II),&#xD;
             uncontrollable severe arrhythmia);&#xD;
&#xD;
          -  Patients occurred myocardial infarction within 6 months;&#xD;
&#xD;
          -  Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary&#xD;
             fibrosis, or CT or MRI reminder ILD ;&#xD;
&#xD;
          -  Patients with clinical symptoms, required clinical intervention or stable time less&#xD;
             than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);&#xD;
&#xD;
          -  Patients with active hepatitis B or active hepatitis C, etc. (for patients with a&#xD;
             history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV&#xD;
             RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that&#xD;
             there may be HIV infection, there is no need to detect);&#xD;
&#xD;
          -  Patients with uncontrolled active infections before enrollment 2 weeks (except simple&#xD;
             urinary tract infection or upper respiratory tract infection);&#xD;
&#xD;
          -  Patients have alcohol or drug addiction;&#xD;
&#xD;
          -  Patients with serious abnormal medical, psychological or laboratory results history&#xD;
             which may affect explanation of study results;&#xD;
&#xD;
          -  Subjects are considered not suitable for the study by investigator,who have other&#xD;
             conditions that may affect their adherence and the evaluation of study indicators.,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Foxiao Qiao, Ph D</last_name>
    <phone>18911165421</phone>
    <phone_ext>86-10-58628288</phone_ext>
    <email>Foxiao_qiao@sinocelltech.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>yuxian bai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital.</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>kai zang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>wei li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>yi ba, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carcinoma</keyword>
  <keyword>Carcinoma, Squamous Cell</keyword>
  <keyword>Esophageal Neoplasms</keyword>
  <keyword>Neoplasms, Squamous Cell</keyword>
  <keyword>Esophageal Diseases</keyword>
  <keyword>Epidermal growth factor receptor</keyword>
  <keyword>EGFR</keyword>
  <keyword>SCT200</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>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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/NCT03817567
org study id: SCT200IbmESCC
nct id: NCT03817567
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR
      monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma
      progressed following treatment with taxane/platinum/fluorouracil.
This is a open label, single-arm multicenter phase Ib study,and is designed to evaluate
      Objective Response Rate (ORR) in advanced esophageal squamous cell carcinoma progressed
      following treatment with taxane/platinum/fluorouracil treated with anti-EGFR monoclonal
      antibody SCT200.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: one year
description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
measure: Adverse events (AEs)
time frame: one year
description: AE are assessed according to NCI CTCAE v4.03.
measure: PFS
time frame: one year
description: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.
measure: Duration of response (DOR)
time frame: one year
description: DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first
measure: Overall survival (OS)
time frame: one year
description: OS is defined as time from first dose of SCT200 until the date of death from any cause.
arm group label: recombinant anti-EGFR monoclonal antibody（SCT200）
arm group type: Experimental
description: 6.0mg/kg QW for 6 weeks, then 8.0mg/kg Q2W
intervention type: Drug
intervention name: recombinant anti-EGFR monoclonal antibody
description: Experimental: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.
arm group label: recombinant anti-EGFR monoclonal antibody（SCT200）
other name: SCT200
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Foxiao Qiao, Ph D
phone: 18911165421
phone ext: 86-10-58628288
email: Foxiao_qiao@sinocelltech.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Antibodies
mesh term: Antibodies, Monoclonal