Clinical trial NCT05606094: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT)
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Duration of Therapy for Each Regimen
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Reasons for Stopping Treatments in Each Line of Treatment (LOT)
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Treatment Sequencing Pathways
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Percentage of Participants Receiving Locoregional Treatment for Localized Disease and Metastasis (Radiotherapy and/or Surgery)
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Secondary outcomes:
measure: Real World Progression Free Survival
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Real Word Overall Survival
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Real World Time to Treatment Failure
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Real World Time to Discontinuation
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Real-world Time to Next Treatment
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Real Word Objective Response Rate
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Real World Disease Control Rate
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Number of Deaths in Each Line of Treatment
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Cause of Death in Each Line of Treatment
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
measure: Number of Participants with Adverse Events of Special Interest (AESI) In Each Line of Treatment
timeFrame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hubei
country: China
facility: Hubei Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Hospital
city: Zhejiang
country: China
facility: Second Affiliated Hospital ZheJiang University School of Medicine
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Pok Fu Lam
country: Hong Kong
facility: Queen Mary Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chillgok Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References: