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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.
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). This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-positive gastric/gastroesophageal junction adenocarcinoma | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world Time to Treatment Failure (rwTTF) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade | 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. |
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Participants must meet all the following inclusion criteria to be eligible for the study:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from the study:
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Eligible participants for this study include participants with HER2-positive local advanced or metastatic GC/GEJA.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Contact | 908-992-6400 | CTRinfo_us@daiichisankyo.com |
| Name | Affiliation | Role |
|---|---|---|
| Project Manager | Daiichi Sankyo Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | 100029 | China |
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| 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 |
| Real-world Time to Next Treatment (rwTTNT) | rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death. | 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 |
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | 100032 | China |
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| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
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| Beijing Cancer Hospital | Recruiting | Beijing | 100142 | China |
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| Beijing GoBroad Hospital | Recruiting | Beijing | 102206 | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | 130031 | China |
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| Changzhi People's Hospital | Recruiting | Changzhi | 046000 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | 350000 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | 510080 | China |
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| The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | 510080 | China |
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| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Recruiting | Guangzhou | 510095 | China |
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| Guangdong Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | 510120 | China |
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| Hainan General Hospital | Recruiting | Haikou | 570100 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | 310005 | China |
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| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | 310009 | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | 310009 | China |
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| Anhui Province Cancer Hoospital | Recruiting | Hefei | 236000 | China |
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| Jiangmen Central Hospital | Recruiting | Jiangmen | 529000 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | 210000 | China |
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| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | 210009 | China |
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| Shanghai GoBroad Cancer Hospital | Recruiting | Shanghai | 200003 | China |
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| Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | 200011 | China |
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| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
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| Zhongshan Hospital | Recruiting | Shanghai | 200032 | China |
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| Huadong Hospital Affiliated to Fudan University | Recruiting | Shanghai | 201104 | China |
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| Cancer Hospital of Shantou University Medical College | Recruiting | Shantou | 515000 | China |
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| Liaoning Cancer Hospital | Not yet recruiting | Shenyang | 110000 | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | 030000 | China |
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| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | 317700 | China |
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| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | 300000 | China |
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| The Second Hospital of Tianjin Medical University | Not yet recruiting | Tianjin | 300211 | China |
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| The Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | 710061 | China |
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| The Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | 361003 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | 221006 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | 450008 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | 450066 | China |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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