Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Stomach Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Sichuan Cancer Hospital
Chengdu, 610041
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangdong, 510060
ChinaSite Not Available
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
ChinaSite Not Available
Hubei Cancer Hospital
Hubei, 430079
ChinaSite Not Available
Shanghai Changhai Hospital
Shanghai, 200433
ChinaSite Not Available
Tianjin Medical University Hospital
Tianjin, 300060
ChinaSite Not Available
Second Affiliated Hospital ZheJiang University School of Medicine
Zhejiang, 310017
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, 450003
ChinaSite Not Available
Queen Mary Hospital
Pok Fu Lam,
Hong KongSite Not Available
Prince of Wales Hospital
Sha Tin,
Hong KongSite Not Available
Tuen Mun Hospital
Tuen Mun,
Hong KongSite Not Available
Dong-A University Hospital
Busan,
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
Cheongju-si, 28644
Korea, Republic ofSite Not Available
Kyungpook National University Chillgok Hospital
Deagu,
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Gyeongsangnam-do,
Korea, Republic ofSite Not Available
Chung-Ang University Hospital
Seoul, 06973
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 04514
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Chiayi Chang Gung Memorial Hospital
Chiayi City, 61363
TaiwanSite Not Available
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung,
TaiwanSite Not Available
Kaohsiung Medical University Hospital
Kaohsiung,
TaiwanSite Not Available
China Medical University Hospital
Taichung,
TaiwanSite Not Available
Chi Mei Medical Center
Tainan,
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
Koo Foundation Sun Yat-Sen Cancer Center
Taipei,
TaiwanSite Not Available
MacKay Memorial Hospital
Taipei,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 112
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
TaiwanSite Not Available
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