Gastric CancerNCT05606094
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
An observational study of Gastric Cancer, run by Daiichi Sankyo Co., Ltd. at 31 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 450 participants
- Where
- 31 sitesin 4 countries
- Study dates
- 9 Mar 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.)
- 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).
- 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.
- 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.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 4 countries.
31 sites in 4 countries
South Korea10 sites
Dong-A University Hospital
Busan
Chungbuk National University Hospital
Cheongju-si, 28644
Kyungpook National University Chillgok Hospital
Deagu
Pusan National University Yangsan Hospital
Gyeongsangnam-do
Kangbuk Samsung Hospital
Seoul, 04514
Samsung Medical Center
Seoul, 06351
Chung-Ang University Hospital
Seoul, 06973
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Taiwan10 sites
Chiayi Chang Gung Memorial Hospital
Chiayi City, 61363
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan, 704
Chi Mei Medical Center
Tainan
Taipei Veterans General Hospital
Taipei, 112
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
MacKay Memorial Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
China8 sites
Sichuan Cancer Hospital
Chengdu, 610041
Sun Yat-sen University Cancer Center
Guangdong, 510060
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
Hubei Cancer Hospital
Hubei, 430079
Shanghai Changhai Hospital
Shanghai, 200433
Tianjin Medical University Hospital
Tianjin, 300060
Second Affiliated Hospital ZheJiang University School of Medicine
Zhejiang, 310017
Henan Cancer Hospital
Zhengzhou, 450003
Hong Kong3 sites
Queen Mary Hospital
Pok Fu Lam
Prince of Wales Hospital
Shatin
Tuen Mun Hospital
Tuenmen
About this study
Official title: A Multinational, Multicenter, Non-Interventional, Retrospective, Observational, Real-World Study: Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in East Asia (HER2+ GASTA Study)
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.
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start9 Mar 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606094
- Sponsor's protocol ID
- DS-ASCAHQ-ENH-GC001
- Status last verified
- Dec 2023
- First submitted
- 18 Oct 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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/
Publications
Oh DY, Yeo W, Chen JS, Ba Y, Chan WWL, Chen MJ, Chen YH, Gu K, Hung YP, Kim JG, Lee J, Liang X, Luo S, Rha SY, Yuan Y, Kim T, Yanagida M, Sato R, Xu RH. A Multinational, Retrospective, Real-World Study: Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Beyond First-line in East Asia (HER2+ GASTA Study). Cancer Res Treat. 2026 Jun 22. doi: 10.4143/crt.2025.1341. Online ahead of print.
PubMed 42341842
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Non-Interventional, Retrospective, Observational, Real-World Study: Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in East Asia (HER2+ GASTA Study)
- ClinicalTrials.gov ID
- NCT05606094
- Acronym / sponsor ID
- DS-ASCAHQ-ENH-GC001
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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.)
- 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).
- 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.
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT)
Time frame: 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
Time frame: 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)
Time frame: 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.
Treatment Sequencing Pathways
Time frame: 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 Locoregional Treatment for Localized Disease and Metastasis (Radiotherapy and/or Surgery)
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 locoregional treatment for metastasis (radiotherapy and/or surgery) since 1st LOT initiation will be assessed.
10 secondary outcomes
Real World Progression Free Survival
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Real Word Overall Survival
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 42341842Oh DY, Yeo W, Chen JS, Ba Y, Chan WWL, Chen MJ, Chen YH, Gu K, Hung YP, Kim JG, Lee J, Liang X, Luo S, Rha SY, Yuan Y, Kim T, Yanagida M, Sato R, Xu RH. A Multinational, Retrospective, Real-World Study: Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Beyond First-line in East Asia (HER2+ GASTA Study). Cancer Res Treat. 2026 Jun 22. doi: 10.4143/crt.2025.1341. Online ahead of print.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Leader study director
Daiichi Sankyo
31 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Daiichi Sankyo Co., Ltd. at 31 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in South Korea, Taiwan, China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT) (time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.