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)

July 7, 2025 updated by: Daiichi Sankyo

Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China: A Nation-wide, Multi-center, Prospective, Non-interventional Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the effectiveness of T-DXd in real-world setting (real-word time to treatment failure).

The secondary objectives of this study are to assess the safety profile of T-DXd (treatment related adverse events [TRAE] regardless of grade, and physician reported adverse events of special interest [AESI] regardless of grade, etc.) and to evaluate effectiveness of T-DXd (real-world time to next treatment). This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd will be enrolled in this study.

Study Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 102206
        • Recruiting
        • Beijing GoBroad Hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 100032
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Principal Investigator
      • Changchun, China, 130031
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Principal Investigator
      • Changzhi, China, 046000
        • Recruiting
        • Changzhi People's Hospital
        • Contact:
          • Principal Investigator
      • Fuzhou, China, 350000
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510095
        • Recruiting
        • Affiliated Cancer Hospital and institute of Guangzhou Medical University
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510120
        • Recruiting
        • Guangdong Hospital of Traditional Chinese Medicine
        • Contact:
          • Principal Investigator
      • Haikou, China, 570100
        • Recruiting
        • Hainan General Hospital
        • Contact:
          • Principal Investigator
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Principal Investigator
      • Hangzhou, China, 310005
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Principal Investigator
      • Hangzhou, China, 310009
        • Not yet recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
          • Principal Investigator
      • Hefei, China, 236000
        • Recruiting
        • Anhui Province Cancer Hoospital
        • Contact:
          • Principal Investigator
      • Jiangmen, China, 529000
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
          • Principal Investigator
      • Nanjing, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Principal Investigator
      • Nanjing, China, 210009
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200011
        • Not yet recruiting
        • Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200003
        • Recruiting
        • Shanghai GoBroad Cancer Hospital
        • Contact:
          • Principal Investigator
      • Shanghai, China, 201104
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University
        • Contact:
          • Principal Investigator
      • Shantou, China, 515000
        • Recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
          • Principal Investigator
      • Shenyang, China, 110000
        • Not yet recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Principal Investigator
      • Taiyuan, China, 030000
        • Recruiting
        • Shanxi Cancer hospital
        • Contact:
          • Principal Investigator
      • Taizhou, China, 317700
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Principal Investigator
      • Tianjin, China, 300211
        • Not yet recruiting
        • The Second Hospital Of Tianjin Medical University
        • Contact:
          • Principal Investigator
      • Tianjin, China, 300000
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Principal Investigator
      • Xi'an, China, 710061
        • Recruiting
        • The Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Principal Investigator
      • Xiamen, China, 361003
        • Not yet recruiting
        • The Affiliated Hospital of Xiamen University
        • Contact:
          • Principal Investigator
      • Xuzhou, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Principal Investigator
      • Zhengzhou, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Principal Investigator
      • Zhengzhou, China, 450066
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible participants for this study include participants with HER2-positive local advanced or metastatic GC/GEJA.

Description

Participants must meet all the following inclusion criteria to be eligible for the study:

  1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
  2. ≥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.
  3. HER2-positive status (IHC 3+ or IHC 2+/ISH +).
  4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
  5. 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.

Exclusion Criteria：

Participants who meet any of the following criteria will be excluded from the study:

  1. Pregnancy or breastfeeding.
  2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
  3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  4. Judged by the investigator to be unfit to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Trastuzumab deruxtecan (T-DXd)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world Time to Treatment Failure (rwTTF)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world Time to Next Treatment (rwTTNT)
Time Frame: 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
rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death.
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
Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade
Time Frame: 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
A TRAE is defined as a harmful reaction, resulting from the normal usage and dosage to a medicinal product, which is unrelated to the purpose of medication. Physician-reported AESIs are defined as interstitial lung disease/pneumonitis and left ventricular ejection fraction decrease.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Investigators

  • Study Director: Project Manager, Daiichi Sankyo (China) Holdings Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-0076-NIS-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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