Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
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.
Exclusion Criteria:
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.
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
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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