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HER2-positive Gastric CancerRECOVERNCT06846996

Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

An observational study of HER2-positive Gastric Cancer and HER2-positive Gastroesophageal Junction, run by Daiichi Sankyo at 40 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab deruxtecan (T-DXd)
Type of treatment
Injection or infusion
How many people
260 participants
Where
40 sitesChina
Study dates
27 Feb 2025to 31 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

40 sites in 1 country

China40 sites, 36 recruiting

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, 100020

    Principal Investigator

    Recruiting

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, 100021

    Principal Investigator

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, 100029

    Principal Investigator

    Recruiting

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, 100032

    Principal Investigator

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100032

    Withdrawn

  • Peking University First Hospital

    Beijing, 100034

    Principal Investigator

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Principal Investigator

    Recruiting

  • Beijing GoBroad Hospital

    Beijing, 102206

    Principal Investigator

    Recruiting

  • The First Hospital of Jilin University

    Changchun, 130031

    Principal Investigator

    Not yet recruiting

  • Changzhi People's Hospital

    Changzhi, 046000

    Principal Investigator

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, 350000

    Principal Investigator

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

    Principal Investigator

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

    Principal Investigator

    Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, 510095

    Principal Investigator

    Recruiting

  • Guangdong Hospital of Traditional Chinese Medicine

    Guangzhou, 510120

    Principal Investigator

    Recruiting

  • Hainan General Hospital

    Haikou, 570100

    Principal Investigator

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310005

    Principal Investigator

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310009

    Withdrawn

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

    Principal Investigator

    Recruiting

  • Anhui Province Cancer Hoospital

    Hefei, 236000

    Principal Investigator

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, 529000

    Principal Investigator

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210000

    Principal Investigator

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, 210009

    Principal Investigator

    Recruiting

  • Shanghai GoBroad Cancer Hospital

    Shanghai, 200003

    Principal Investigator

    Recruiting

  • Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine

    Shanghai, 200011

    Principal Investigator

    Not yet recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

    Principal Investigator

    Recruiting

  • Fudan University Affiliated Cancer Hospital

    Shanghai, 200032

    Principal Investigator

    Recruiting

  • Zhongshan Hospital

    Shanghai, 200032

    Principal Investigator

    Recruiting

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 201104

    Principal Investigator

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515000

    Principal Investigator

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, 110000

    Withdrawn

  • Shanxi Cancer Hospital

    Taiyuan, 030000

    Principal Investigator

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317700

    Principal Investigator

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300000

    Principal Investigator

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

    Principal Investigator

    Recruiting

  • The Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

    Principal Investigator

    Recruiting

  • The Affiliated Hospital of Xiamen University

    Xiamen, 361003

    Principal Investigator

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221006

    Principal Investigator

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Principal Investigator

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450066

    Withdrawn

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Trastuzumab deruxtecan (T-DXd)
Keywords
HER2-positive gastric cancer, HER2-positive gastroesophageal junction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab deruxtecan (T-DXd)Drug

    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.

Study groups in NCT06846996
Study groupRoleWhat they receive
HER2-positive gastric/gastroesophageal junction adenocarcinomaPatients 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.
Receives: Drug: Trastuzumab deruxtecan (T-DXd)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade

    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.

    Measured: 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

  2. Real-world Time to Next Treatment (rwTTNT)

    rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start27 Feb 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846996
Sponsor's protocol ID
DS8201-0076-NIS-MA
Acronym
RECOVER
Status last verified
Aug 2026
First submitted
21 Feb 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HER2-positive Gastric Cancer and HER2-positive Gastroesophageal Junction, run by Daiichi Sankyo at 40 sites in China.

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 0 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT06846996.

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 18 Aug 2026.

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