Actively Recruiting

Age: 18Years +
All Genders
NCT06846996

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

Led by Daiichi Sankyo · Updated on 2025-07-08

260

Participants Needed

36

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 36 locations

1

China-Japan Friendship Hospital

Beijing, China, 100029

Actively Recruiting

2

Peking Union Medical College Hospital

Beijing, China, 100032

Not Yet Recruiting

3

Peking University First Hospital

Beijing, China, 100034

Actively Recruiting

4

Beijing Cancer Hospital

Beijing, China, 100142

Actively Recruiting

5

Beijing GoBroad Hospital

Beijing, China, 102206

Actively Recruiting

6

The First Hospital of Jilin University

Changchun, China, 130031

Not Yet Recruiting

7

Changzhi People's Hospital

Changzhi, China, 046000

Actively Recruiting

8

Fujian Cancer Hospital

Fuzhou, China, 350000

Actively Recruiting

9

Guangdong Provincial People's Hospital

Guangzhou, China, 510080

Actively Recruiting

10

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China, 510080

Actively Recruiting

11

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, China, 510095

Actively Recruiting

12

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, China, 510120

Actively Recruiting

13

Hainan General Hospital

Haikou, China, 570100

Actively Recruiting

14

Zhejiang Cancer Hospital

Hangzhou, China, 310005

Actively Recruiting

15

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China, 310009

Not Yet Recruiting

16

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China, 310009

Actively Recruiting

17

Anhui Province Cancer Hoospital

Hefei, China, 236000

Actively Recruiting

18

Jiangmen Central Hospital

Jiangmen, China, 529000

Actively Recruiting

19

Nanjing Drum Tower Hospital

Nanjing, China, 210000

Actively Recruiting

20

Jiangsu Cancer Hospital

Nanjing, China, 210009

Not Yet Recruiting

21

Shanghai GoBroad Cancer Hospital

Shanghai, China, 200003

Actively Recruiting

22

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

Shanghai, China, 200011

Not Yet Recruiting

23

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China, 200025

Actively Recruiting

24

Zhongshan Hospital

Shanghai, China, 200032

Actively Recruiting

25

Huadong Hospital Affiliated to Fudan University

Shanghai, China, 201104

Actively Recruiting

26

Cancer Hospital of Shantou University Medical College

Shantou, China, 515000

Actively Recruiting

27

Liaoning Cancer Hospital

Shenyang, China, 110000

Not Yet Recruiting

28

Shanxi Cancer Hospital

Taiyuan, China, 030000

Actively Recruiting

29

Taizhou Hospital of Zhejiang Province

Taizhou, China, 317700

Actively Recruiting

30

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China, 300000

Not Yet Recruiting

31

The Second Hospital of Tianjin Medical University

Tianjin, China, 300211

Not Yet Recruiting

32

The Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

Actively Recruiting

33

The Affiliated Hospital of Xiamen University

Xiamen, China, 361003

Not Yet Recruiting

34

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China, 221006

Actively Recruiting

35

Henan Cancer Hospital

Zhengzhou, China, 450008

Actively Recruiting

36

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China, 450066

Not Yet Recruiting

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Research Team

C

Contact for Clinical Trial Information

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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