Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer in East Asia

Last updated: December 8, 2023
Sponsor: Daiichi Sankyo Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Gastric Cancer

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT05606094
DS-ASCAHQ-ENH-GC001
  • Ages > 18
  • All Genders

Study Summary

This study will be conducted to understand real-world treatment patterns, participant characteristics (demographic and clinico-pathological characteristics), clinical outcomes and safety of different treatment regimens, and healthcare resource utilization in East Asia for HER2-positive locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) in a real-world setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants at the time of 1st LOT (Index Date 1e) initiation - Adult patients ≥18 years old. (Please follow local regulatory requirements if the legal age ofconsent for study participation is >18 years old.)
  • Participants or next of kin/legal representatives who are willing to provide writteninformed consent as per the local regulations (if IRB/IEC/EC grants a permission towaive informed consent, it is not necessary).
  • Participants who were pathologically and/or clinically diagnosed with locally advancedor metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease,relapsed/progressed) since January 1, 2016, and its record is available at the studyparticipating site.
  • Participants whose HER2 status were pathologically confirmed HER2-positive (IHC3+ orIHC2+/ISH-positive) before/at the Index Date 2f based on the most recent archivedtumor tissue sample to the Date of Diagnosisg, and its record is available at thestudy participating site.
  • Participants who received at least 1 LOT for HER2-positive locally advanced ormGC/GEJC in an advanced setting, and its record is available at study participatingsite. Trastuzumab or its biosimilar use is not required. °Progression on or within 6 months post neoadjuvant or adjuvant therapy is counted as "rapid progressor" in a neo-adjuvant/adjuvant setting, and thus equivalent toadvanced/metastatic disease failing 1 LOT.
  • Participants who have at least 6 months of follow-up data from the date of 2nd LOTinitiation (Index Date 2f) unless participant died within the first 6 months from theIndex Date 2, and its record is available at the study participating site.
  • For rapid progressor participants in a neo-adjuvant/adjuvant setting, "Index Date 1" will be the date of neo-adjuvant treatment initiation or adjuvant treatmentinitiation.

Exclusion

Exclusion Criteria:

  • Participants with a change in HER2 status from positive to negative at progressionfrom early-stage to advanced-stage disease (change from HER2-positive to HER2-negativeon repeat biopsy during treatment for advanced stage can be participated). However, ifHER2-positive was confirmed before the Date of Diagnosis (or if HER2-positive wasconfirmed using an archived tumor tissue sample collected during early stage) and theresult was followed to make the decision for the 1st LOT, this is not the case.
  • Participants who had multiple cancer within 3 years of 1st LOT initiation (Index Date 1), except adequately resected melanoma skin cancer, curatively treated in-situdisease, other solid tumors curatively treated.
  • Participants who are participating or have participated in an interventional studythat remains blinded at time of informed consent (IC) or at the time of datacollection for participants whose IC is waived by the local IRB/EC/IEC.

Study Design

Total Participants: 450
Study Start date:
March 09, 2023
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • Sichuan Cancer Hospital

    Chengdu, 610041
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangdong, 510060
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022
    China

    Site Not Available

  • Hubei Cancer Hospital

    Hubei, 430079
    China

    Site Not Available

  • Shanghai Changhai Hospital

    Shanghai, 200433
    China

    Site Not Available

  • Tianjin Medical University Hospital

    Tianjin, 300060
    China

    Site Not Available

  • Second Affiliated Hospital ZheJiang University School of Medicine

    Zhejiang, 310017
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450003
    China

    Site Not Available

  • Queen Mary Hospital

    Pok Fu Lam,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Site Not Available

  • Tuen Mun Hospital

    Tuen Mun,
    Hong Kong

    Site Not Available

  • Dong-A University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chillgok Hospital

    Deagu,
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do,
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 04514
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, 61363
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung,
    Taiwan

    Site Not Available

  • Chi Mei Medical Center

    Tainan,
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei,
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305
    Taiwan

    Site Not Available

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