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
- Conditions
- Gastric Cancer
- Registration Number
- NCT05606094
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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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 of consent for study participation is >18 years old.)
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Participants or next of kin/legal representatives who are willing to provide written informed consent as per the local regulations (if IRB/IEC/EC grants a permission to waive informed consent, it is not necessary).
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Participants who were pathologically and/or clinically diagnosed with locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) since January 1, 2016, and its record is available at the study participating site.
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Participants whose HER2 status were pathologically confirmed HER2-positive (IHC3+ or IHC2+/ISH-positive) before/at the Index Date 2f based on the most recent archived tumor tissue sample to the Date of Diagnosisg, and its record is available at the study participating site.
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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.
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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.
- For rapid progressor participants in a neo-adjuvant/adjuvant setting, "Index Date 1" will be the date of neo-adjuvant treatment initiation or adjuvant treatment initiation.
- Participants with a change in HER2 status from positive to negative at progression from early-stage to advanced-stage disease (change from HER2-positive to HER2-negative on repeat biopsy during treatment for advanced stage can be participated). However, if HER2-positive was confirmed before the Date of Diagnosis (or if HER2-positive was confirmed using an archived tumor tissue sample collected during early stage) and the result 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-situ disease, other solid tumors curatively treated.
- Participants who are participating or have participated in an interventional study that remains blinded at time of informed consent (IC) or at the time of data collection for participants whose IC is waived by the local IRB/EC/IEC.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Receiving Locoregional Treatment for Localized Disease and Metastasis (Radiotherapy and/or Surgery) 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 locoregional treatment for metastasis (radiotherapy and/or surgery) since 1st LOT initiation will be assessed.
Treatment Sequencing Pathways From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Treatment sequencing from 1st LOT to 2nd LOT and to the subsequent LOT will be assessed.
Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT) From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months 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.
Duration of Therapy for Each Regimen From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Duration of Therapy (DoT) is defined as the length of time from initiation of each LOT to permanent discontinuation of the treatment.
Reasons for Stopping Treatments in Each Line of Treatment (LOT) From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Reasons for stopping treatments will be ascertained by patient charts and assessed by frequency and percentage.
- Secondary Outcome Measures
Name Time Method Cause of Death in Each Line of Treatment From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Real Word Overall Survival From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Length of time from the date of initiation of LOT to death due to any cause.
Real World Disease Control Rate From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Proportion of participants with real-world complete response, real-world partial response and real-world stable disease during treatment for each LOT.
Real-world Time to Next Treatment From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months 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.
Real World Time to Discontinuation From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months 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.
Real Word Objective Response Rate From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months Proportion of participants who achieved real-world complete response or real-world partial response to treatment for each LOT.
Real World Progression Free Survival From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months 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.
Real World Time to Treatment Failure From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months 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.
Number of Deaths in Each Line of Treatment 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 From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Trial Locations
- Locations (31)
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
MacKay Memorial Hospital
🇨🇳Taipei, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Sun Yat-sen University Cancer Center
🇨🇳Guangdong, China
Hubei Cancer Hospital
🇨🇳Hubei, China
Shanghai Changhai Hospital
🇨🇳Shanghai, China
Queen Mary Hospital
🇭🇰Pok Fu Lam, Hong Kong
Tianjin Medical University Hospital
🇨🇳Tianjin, China
Second Affiliated Hospital ZheJiang University School of Medicine
🇨🇳Zhejiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chillgok Hospital
🇰🇷Deagu, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chiayi Chang Gung Memorial Hospital
🇨🇳Chiayi City, Taiwan
Tuen Mun Hospital
🇭🇰Tuen Mun, Hong Kong
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Prince of Wales Hospital
🇭🇰Sha Tin, Hong Kong