<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/NCT03024450</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-ON-08</org_study_id>
    <nct_id>NCT03024450</nct_id>
  </id_info>
  <brief_title>Trastuzumab Based Therapy in HER2 Positive AGC</brief_title>
  <official_title>Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric&#xD;
      cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with&#xD;
      clinicopathologic factors remain unclear. The object of the study is to determine whether the&#xD;
      addition of trastuzumab to first-line chemotherapy improves efficacy compared with&#xD;
      chemotherapy alone in HER2 positive AGC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational&#xD;
      study. All patients were treated with trastuzumab plus chemotherapy as the first line&#xD;
      therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data&#xD;
      were collected to evaluate the potential prognostic factors on progressive free survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>8 Years</target_duration>
  <primary_outcome>
    <measure>OS</measure>
    <time_frame>8 years</time_frame>
    <description>OS was defined as time from the beginning of first line therapy to death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>8 years</time_frame>
    <description>PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">98</enrollment>
  <condition>Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>HER2 positive AGC treated with H+CT</arm_group_label>
    <description>HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>H+CT</intervention_name>
    <description>All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.</description>
    <arm_group_label>HER2 positive AGC treated with H+CT</arm_group_label>
    <other_name>trastuzumab plus chemotherapy</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      spicimen with paraffin-embedded obtained by gastroscope or surgery&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with HER2 positive advanced or metastatic gastric adenocarcinoma in&#xD;
        Shanghai Zhongshan Hospital, Fu Dan University were prospectively collected. HER2&#xD;
        expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ&#xD;
        hybridization (FISH) was used to detect HER2/neu amplification levels.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;&#xD;
&#xD;
          2. received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;&#xD;
&#xD;
          3. with measurable lesion with a diameter 20 mm using conventional computed tomography&#xD;
             (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;&#xD;
&#xD;
          5. left ventricular ejection fraction(LVEF) more than 50 percents;&#xD;
&#xD;
          6. sufficient bone marrow, liver and renal function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant&#xD;
             chemotherapy completed at least 6 months before enrollment);&#xD;
&#xD;
          2. trastuzumab based adjuvant/neoadjuvant therapy;&#xD;
&#xD;
          3. treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);&#xD;
&#xD;
          4. patients with heart failure, coronary artery disease or myocardial infarction within&#xD;
             the previous 6 months.&#xD;
&#xD;
          5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses&#xD;
             of AGC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tianshu / Liu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Hospital Affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.</citation>
    <PMID>20728210</PMID>
  </results_reference>
  <results_reference>
    <citation>Halon A, Donizy P, Biecek P, Rudno-Rudzinska J, Kielan W, Matkowski R. HER-2 expression in immunohistochemistry has no prognostic significance in gastric cancer patients. ScientificWorldJournal. 2012;2012:941259. doi: 10.1100/2012/941259. Epub 2012 May 3.</citation>
    <PMID>22645475</PMID>
  </results_reference>
  <results_reference>
    <citation>Shitara K, Yatabe Y, Matsuo K, Sugano M, Kondo C, Takahari D, Ura T, Tajika M, Ito S, Muro K. Prognosis of patients with advanced gastric cancer by HER2 status and trastuzumab treatment. Gastric Cancer. 2013 Apr;16(2):261-7. doi: 10.1007/s10120-012-0179-9. Epub 2012 Jul 14.</citation>
    <PMID>22797858</PMID>
  </results_reference>
  <results_reference>
    <citation>Gomez-Martin C, Lopez-Rios F, Aparicio J, Barriuso J, Garcia-Carbonero R, Pazo R, Rivera F, Salgado M, Salud A, Vazquez-Sequeiros E, Lordick F. A critical review of HER2-positive gastric cancer evaluation and treatment: from trastuzumab, and beyond. Cancer Lett. 2014 Aug 28;351(1):30-40. doi: 10.1016/j.canlet.2014.05.019. Epub 2014 Jun 3.</citation>
    <PMID>24943493</PMID>
  </results_reference>
  <results_reference>
    <citation>Gong J, Liu T, Fan Q, Bai L, Bi F, Qin S, Wang J, Xu N, Cheng Y, Bai Y, Liu W, Wang L, Shen L. Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial. BMC Cancer. 2016 Feb 8;16:68. doi: 10.1186/s12885-016-2092-9.</citation>
    <PMID>26857702</PMID>
  </results_reference>
  <results_reference>
    <citation>Jiang H, Li Q, Yu S, Yu Y, Wang Y, Li W, Cui Y, Liu T. Impact of HER2 expression on outcome in gastric cancer patients with liver metastasis. Clin Transl Oncol. 2017 Feb;19(2):197-203. doi: 10.1007/s12094-016-1523-z. Epub 2016 Jun 20.</citation>
    <PMID>27324991</PMID>
  </results_reference>
  <results_reference>
    <citation>Aizawa M, Nagatsuma AK, Kitada K, Kuwata T, Fujii S, Kinoshita T, Ochiai A. Evaluation of HER2-based biology in 1,006 cases of gastric cancer in a Japanese population. Gastric Cancer. 2014 Jan;17(1):34-42. doi: 10.1007/s10120-013-0239-9. Epub 2013 Feb 22.</citation>
    <PMID>23430266</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Tianshu Liu</investigator_full_name>
    <investigator_title>Chief doctor and director of Department of medical oncology</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>HER2</keyword>
  <keyword>trastuzumab</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03024450
org study id: ZS-ON-08
nct id: NCT03024450
lead sponsor: 
has dmc: No
Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric
      cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with
      clinicopathologic factors remain unclear. The object of the study is to determine whether the
      addition of trastuzumab to first-line chemotherapy improves efficacy compared with
      chemotherapy alone in HER2 positive AGC.
A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational
      study. All patients were treated with trastuzumab plus chemotherapy as the first line
      therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data
      were collected to evaluate the potential prognostic factors on progressive free survival.
observational model: Cohort
time perspective: Prospective
measure: OS
time frame: 8 years
description: OS was defined as time from the beginning of first line therapy to death
measure: PFS
time frame: 8 years
description: PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.
arm group label: HER2 positive AGC treated with H+CT
description: HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.
intervention type: Drug
intervention name: H+CT
description: All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.
arm group label: HER2 positive AGC treated with H+CT
other name: trastuzumab plus chemotherapy
spicimen with paraffin-embedded obtained by gastroscope or surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tianshu / Liu, Doctor
role: Principal Investigator
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
citation: Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.
PMID: 20728210
citation: Halon A, Donizy P, Biecek P, Rudno-Rudzinska J, Kielan W, Matkowski R. HER-2 expression in immunohistochemistry has no prognostic significance in gastric cancer patients. ScientificWorldJournal. 2012;2012:941259. doi: 10.1100/2012/941259. Epub 2012 May 3.
PMID: 22645475
citation: Shitara K, Yatabe Y, Matsuo K, Sugano M, Kondo C, Takahari D, Ura T, Tajika M, Ito S, Muro K. Prognosis of patients with advanced gastric cancer by HER2 status and trastuzumab treatment. Gastric Cancer. 2013 Apr;16(2):261-7. doi: 10.1007/s10120-012-0179-9. Epub 2012 Jul 14.
PMID: 22797858
citation: Gomez-Martin C, Lopez-Rios F, Aparicio J, Barriuso J, Garcia-Carbonero R, Pazo R, Rivera F, Salgado M, Salud A, Vazquez-Sequeiros E, Lordick F. A critical review of HER2-positive gastric cancer evaluation and treatment: from trastuzumab, and beyond. Cancer Lett. 2014 Aug 28;351(1):30-40. doi: 10.1016/j.canlet.2014.05.019. Epub 2014 Jun 3.
PMID: 24943493
citation: Gong J, Liu T, Fan Q, Bai L, Bi F, Qin S, Wang J, Xu N, Cheng Y, Bai Y, Liu W, Wang L, Shen L. Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial. BMC Cancer. 2016 Feb 8;16:68. doi: 10.1186/s12885-016-2092-9.
PMID: 26857702
citation: Jiang H, Li Q, Yu S, Yu Y, Wang Y, Li W, Cui Y, Liu T. Impact of HER2 expression on outcome in gastric cancer patients with liver metastasis. Clin Transl Oncol. 2017 Feb;19(2):197-203. doi: 10.1007/s12094-016-1523-z. Epub 2016 Jun 20.
PMID: 27324991
citation: Aizawa M, Nagatsuma AK, Kitada K, Kuwata T, Fujii S, Kinoshita T, Ochiai A. Evaluation of HER2-based biology in 1,006 cases of gastric cancer in a Japanese population. Gastric Cancer. 2014 Jan;17(1):34-42. doi: 10.1007/s10120-013-0239-9. Epub 2013 Feb 22.
PMID: 23430266
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Tianshu Liu
investigator title: Chief doctor and director of Department of medical oncology
mesh term: Adenocarcinoma
mesh term: Trastuzumab
sharing ipd: No