NCT06846996Toboroz
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 18.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 260 (tervezett)
- Első benyújtás
- 2025. febr. 21.
- Kezdés
- 2025. febr. 27.
- Elsődleges befejezés
- 2027. júl. 31.
- Fő szponzor
- Daiichi Sankyo
- Betegségek
- Gyomor- és nyelőcsőrák
- NCT-szám
- NCT06846996
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 260
- 2025. febr. 27. és az elsődleges befejezés (2027. júl. 31.) között
- 40 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
Egyéb
- 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.
- Judged by the investigator to be unfit to participate in the study.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (40)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Kína | Toboroz |
| China-Japan Friendship Hospital | Beijing | Kína | Toboroz |
| Peking University First Hospital | Beijing | Kína | Toboroz |
| Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Kína | Toboroz |
| Beijing Cancer Hospital | Beijing | Kína | Toboroz |
| Beijing GoBroad Hospital | Beijing | Kína | Toboroz |
| Peking Union Medical College Hospital | Beijing | Kína | Visszavonva |
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | Kína | Toboroz |
| The First Hospital of Jilin University | Changchun | Kína | Toborzás még nem indult |
| Changzhi People's Hospital | Changzhi | Kína | Toboroz |
| Fujian Cancer Hospital | Fuzhou | Kína | Toboroz |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Kína | Toboroz |
| Guangdong Provincial People's Hospital | Guangzhou | Kína | Toboroz |
| Guangdong Hospital of Traditional Chinese Medicine | Guangzhou | Kína | Toboroz |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | Kína | Toboroz |
| Hainan General Hospital | Haikou | Kína | Toboroz |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Kína | Toboroz |
| Zhejiang Cancer Hospital | Hangzhou | Kína | Toboroz |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Kína | Visszavonva |
| Anhui Province Cancer Hoospital | Hefei | Kína | Toboroz |
| Jiangmen Central Hospital | Jiangmen | Kína | Toboroz |
| Jiangsu Cancer Hospital | Nanjing | Kína | Toboroz |
| Nanjing Drum Tower hospital | Nanjing | Kína | Toboroz |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Kína | Toboroz |
| Fudan University Affiliated Cancer Hospital | Shanghai | Kína | Toboroz |
| Shanghai GoBroad Cancer Hospital | Shanghai | Kína | Toboroz |
| Huadong Hospital Affiliated to Fudan University | Shanghai | Kína | Toboroz |
| Zhongshan Hospital | Shanghai | Kína | Toboroz |
| Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Kína | Toborzás még nem indult |
| Cancer Hospital of Shantou University Medical College | Shantou | Kína | Toboroz |
| Liaoning Cancer Hospital | Shenyang | Kína | Visszavonva |
| Shanxi Cancer hospital | Taiyuan | Kína | Toboroz |
| Taizhou Hospital of Zhejiang Province | Taizhou | Kína | Toboroz |
| The Second Hospital of Tianjin Medical University | Tianjin | Kína | Toboroz |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Kína | Toboroz |
| The Affiliated Hospital of Xiamen University | Xiamen | Kína | Toboroz |
| The Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Kína | Toboroz |
| The affiliated hospital of xuzhou medical university | Xuzhou | Kína | Toboroz |
| Henan Cancer Hospital | Zhengzhou | Kína | Toboroz |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Kína | Visszavonva |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.