Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
RECOVER
1 other identifier
observational
260
1 country
36
Brief Summary
Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
July 8, 2025
July 1, 2025
2.4 years
February 21, 2025
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Real-world Time to Treatment Failure (rwTTF)
rwTTF is defined as time from T-DXd treatment initiation date to the earliest date of treatment discontinuation due to disease progression, physician decision, adverse events or death.
T-DXd treatment initiation date (index date) to date of treatment discontinuation due to disease progression, physician decision, adverse events or death, whichever occurs first, up to approximately 2 years
Secondary Outcomes (2)
Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade
T-DXd treatment initiation date (index date) until end of study, or death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first, up to approximately 2 years
Real-world Time to Next Treatment (rwTTNT)
T-DXd treatment initiation date (index date) to the date of receiving next line anti-cancer treatment or death, whichever occurs first, up to approximately 2 years
Study Arms (1)
HER2-positive gastric/gastroesophageal junction adenocarcinoma
Patients who are diagnosed with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who made a decision (prior to enrolling in this study) to receive T-DXd treatment in a clinical practice setting.
Interventions
This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd (starting dose 6.4 mg/kg IV Q3W) will be enrolled in this study as part of clinical routine or the clinical judgement of physician.
Eligibility Criteria
Eligible participants for this study include participants with HER2-positive local advanced or metastatic GC/GEJA.
You may qualify if:
- Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
- ≥18 years of age at the time of starting the first dose of T-DXd and signing informed consent form (ICF), capable of providing informed consent.
- HER2-positive status (IHC 3+ or IHC 2+/ISH +).
- Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
- Decision to newly initiate T-DXd before study ICF signing. If the participants have started the first dose of T-DXd no longer than 21 days before enrollment, they could be enrolled if the signed and dated ICF could be obtained.
You may not qualify if:
- Participants who meet any of the following criteria will be excluded from the study:
- Pregnancy or breastfeeding.
- Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
- Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Judged by the investigator to be unfit to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (36)
China-Japan Friendship Hospital
Beijing, 100029, China
Peking Union Medical College Hospital
Beijing, 100032, China
Peking University First Hospital
Beijing, 100034, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing GoBroad Hospital
Beijing, 102206, China
The First Hospital of Jilin University
Changchun, 130031, China
Changzhi People's Hospital
Changzhi, 046000, China
Fujian Cancer Hospital
Fuzhou, 350000, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, 510095, China
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, 510120, China
Hainan General Hospital
Haikou, 570100, China
Zhejiang Cancer Hospital
Hangzhou, 310005, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310009, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Anhui Province Cancer Hoospital
Hefei, 236000, China
Jiangmen Central Hospital
Jiangmen, 529000, China
Nanjing Drum Tower Hospital
Nanjing, 210000, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Shanghai GoBroad Cancer Hospital
Shanghai, 200003, China
Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, 200011, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Zhongshan Hospital
Shanghai, 200032, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 201104, China
Cancer Hospital of Shantou University Medical College
Shantou, 515000, China
Liaoning Cancer Hospital
Shenyang, 110000, China
Shanxi Cancer Hospital
Taiyuan, 030000, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317700, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300000, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
The Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
The Affiliated Hospital of Xiamen University
Xiamen, 361003, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006, China
Henan Cancer Hospital
Zhengzhou, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450066, China
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Project Manager
Daiichi Sankyo Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 26, 2025
Study Start
February 27, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
July 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share