Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.

Judged by the investigator to be unfit to participate in the study.

Trial design

Treatments tested in this trial

  • Trastuzumab deruxtecan (T-DXd)

Treatment groups

260 Participants
are divided into 1 treatment group

Sponsors and collaborators