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NCT06846996Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
260 (estimated)
First submitted
21 Feb 2025
Start date
27 Feb 2025
Primary completion date
31 Jul 2027
Lead sponsor
Daiichi Sankyo
NCT number
NCT06846996

What you commit to

  • Study type: Observational
  • Planned participants: 260
  • From 27 Feb 2025 to the primary completion date, 31 Jul 2027
  • 40 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.

Other

  • 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.
  • Judged by the investigator to be unfit to participate in the study.

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Peking University First Hospital
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BeijingChinaRecruiting
Chinese Academy of Medical Sciences Cancer Hospital
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BeijingChinaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
Beijing GoBroad Hospital
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BeijingChinaRecruiting
Peking Union Medical College Hospital
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BeijingChinaWithdrawn
Beijing Chaoyang Hospital, Capital Medical University
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BeijingChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaNot yet recruiting
Changzhi People's Hospital
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ChangzhiChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
Guangdong Hospital of Traditional Chinese Medicine
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GuangzhouChinaRecruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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GuangzhouChinaRecruiting
Hainan General Hospital
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HaikouChinaRecruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaWithdrawn
Anhui Province Cancer Hoospital
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HefeiChinaRecruiting
Jiangmen Central Hospital
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JiangmenChinaRecruiting
Jiangsu Cancer Hospital
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NanjingChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaRecruiting
Fudan University Affiliated Cancer Hospital
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ShanghaiChinaRecruiting
Shanghai GoBroad Cancer Hospital
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ShanghaiChinaRecruiting
Huadong Hospital Affiliated to Fudan University
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ShanghaiChinaRecruiting
Zhongshan Hospital
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ShanghaiChinaRecruiting
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaNot yet recruiting
Cancer Hospital of Shantou University Medical College
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ShantouChinaRecruiting
Liaoning Cancer Hospital
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ShenyangChinaWithdrawn
Shanxi Cancer hospital
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TaiyuanChinaRecruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaRecruiting
The Second Hospital of Tianjin Medical University
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TianjinChinaRecruiting
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaRecruiting
The Affiliated Hospital of Xiamen University
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XiamenChinaRecruiting
The Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaRecruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaWithdrawn

This page is information, not medical advice. Discuss any trial with your doctor.