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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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

260

Start Date

2025-02-27

Completion Date

2027-07-31

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

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.

Locations (36)

China-Japan Friendship Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

Beijing GoBroad Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Changzhi People's Hospital

Changzhi, China

Fujian Cancer Hospital

Fuzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, China

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, China

Hainan General Hospital

Haikou, China

Zhejiang Cancer Hospital

Hangzhou, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Anhui Province Cancer Hoospital

Hefei, China

Jiangmen Central Hospital

Jiangmen, China

Nanjing Drum Tower Hospital

Nanjing, China

Jiangsu Cancer Hospital

Nanjing, China

Shanghai GoBroad Cancer Hospital

Shanghai, China

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

Shanghai, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Zhongshan Hospital

Shanghai, China

Huadong Hospital Affiliated to Fudan University

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Liaoning Cancer Hospital

Shenyang, China

Shanxi Cancer Hospital

Taiyuan, China

Taizhou Hospital of Zhejiang Province

Taizhou, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

The Second Hospital of Tianjin Medical University

Tianjin, China

The Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The Affiliated Hospital of Xiamen University

Xiamen, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China