An observational study in Gastric Cancer, sponsored by Daiichi Sankyo Co., Ltd.. Completed at 31 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Daiichi Sankyo Co., Ltd. · Observational
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 450 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Daiichi Sankyo Co., Ltd. is the lead sponsor of 72 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
The target population for data collection of this study is the participants who were diagnosed with HER2-positive locally advanced or mGC/GEJC (adenocarcinoma, de novo advanced disease, relapsed/progressed), since 1 January, 2016, having completed at least 1 LOT with availability of 6 months follow-up data from the date of 2nd LOT initiation unless participant died within the first 6 months since the 2nd LOT initiation in an advanced setting in East Asia.
Participants who received at least 1 LOT for HER2-positive locally advanced or mGC/GEJC in an advanced setting, and its record is available at study participating site. 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 to advanced/metastatic disease failing 1 LOT.
Participants who have at least 6 months of follow-up data from the date of 2nd LOT initiation (Index Date 2f) unless participant died within the first 6 months from the Index Date 2, and its record is available at the study participating site.
Exclusion Criteria:
Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT)
Percentage of participants receiving each regimen in each line of treatment (LOT) since 1st LOT initiation will be assessed. LOT is defined as one regimen, possibly a combination of several drugs, given from the date of initiation of each LOT until the treatment failed to control the disease, is not tolerated by the participant, at the time of disease relapse/progression or death.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Duration of Therapy for Each Regimen
Duration of Therapy (DoT) is defined as the length of time from initiation of each LOT to permanent discontinuation of the treatment.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Reasons for Stopping Treatments in Each Line of Treatment (LOT)
Reasons for stopping treatments will be ascertained by patient charts and assessed by frequency and percentage.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Treatment Sequencing Pathways
Treatment sequencing from 1st LOT to 2nd LOT and to the subsequent LOT will be assessed.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Percentage of Participants Receiving Locoregional Treatment for Localized Disease and Metastasis (Radiotherapy and/or Surgery)
Percentage of participants receiving locoregional treatment for localized disease and locoregional treatment for metastasis (radiotherapy and/or surgery) since 1st LOT initiation will be assessed.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real World Progression Free Survival
Length of time from the date of initiation of LOT to the date of real-world disease progression or death due to any cause, whichever comes first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real Word Overall Survival
Length of time from the date of initiation of LOT to death due to any cause.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real World Time to Treatment Failure
Length of time from the initiation of LOT to the date of real-world disease progression, treatment discontinuation, or death due to any cause, whichever occurs first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real World Time to Discontinuation
Length of time from the date the participant initiates the LOT to the date the participant discontinues that LOT or death due to any cause, whichever occurs first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real-world Time to Next Treatment
Length of time from the date the participant initiates the LOT to the date the participant initiates next LOT or death from any cause, whichever occurs first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real Word Objective Response Rate
Proportion of participants who achieved real-world complete response or real-world partial response to treatment for each LOT.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real World Disease Control Rate
Proportion of participants with real-world complete response, real-world partial response and real-world stable disease during treatment for each LOT.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Number of Deaths in Each Line of Treatment
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Cause of Death in Each Line of Treatment
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Number of Participants with Adverse Events of Special Interest (AESI) In Each Line of Treatment
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Plan to share: Yes — De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Daiichi Sankyo Co., Ltd.