Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced o… (NCT06846996) | Clinical Trial Compass
RecruitingNot Applicable
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
China260 participantsStarted 2025-02-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Real-world Time to Treatment Failure (rwTTF)
Timeframe: 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