Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
- Conditions
- HER2-positive Gastric CancerHER2-positive Gastroesophageal Junction
- Interventions
- Registration Number
- NCT06846996
- Lead Sponsor
- Daiichi Sankyo
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HER2-positive gastric/gastroesophageal junction adenocarcinoma Trastuzumab deruxtecan (T-DXd) Patients 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.
- Primary Outcome Measures
Name Time Method Real-world Time to Treatment Failure (rwTTF) 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 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade 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 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.
Real-world Time to Next Treatment (rwTTNT) 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 rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death.
Related Research Topics
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Trial Locations
- Locations (30)
Peking Union Medical College Hospital
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, China
Beijing Cancer 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
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
Anhui Province Cancer Hoospital
🇨🇳Hefei, China
Nanjing Drum Tower 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
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Huadong Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, China
Liaoning Cancer Hospital
🇨🇳Shenyang, China
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
🇨🇳Shijiazhuang, 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
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China