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.
Study Type
OBSERVATIONAL
Enrollment
450
Sichuan Cancer Hospital
Chengdu, China
Sun Yat-sen University Cancer Center
Guangdong, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Hubei Cancer Hospital
Hubei, China
Shanghai Changhai Hospital
Shanghai, China
Tianjin Medical University Hospital
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.
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Tianjin, China
Second Affiliated Hospital ZheJiang University School of Medicine
Zhejiang, China
Henan Cancer Hospital
Zhengzhou, China
Queen Mary Hospital
Pok Fu Lam, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
...and 21 more locations
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