Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06846996

RecruitingN/A

Sponsor: Daiichi Sankyo

Conditions: HER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction

Interventions: Trastuzumab deruxtecan (T-DXd)

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Participants must meet all the following inclusion criteria to be eligible for the study:

1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
2. ≥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.
3. HER2-positive status (IHC 3+ or IHC 2+/ISH +).
4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
5. 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:

1. Pregnancy or breastfeeding.
2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
4. Judged by the investigator to be unfit to participate in the study.
Locations (40)
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Changzhi, China
  • Fuzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Haikou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hefei, China
  • Jiangmen, China
  • Nanjing, China
  • Nanjing, China
  • Shanghai, China
  • Shanghai, China
  • Shanghai, China
  • Shanghai, China
  • Shanghai, China
  • Shanghai, China
  • Shantou, China
  • + 10 more on CT.gov