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

Sponsor
Daiichi Sankyo
Study ID
NCT06846996
Status
Recruiting
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Conditions

  • HER2-positive Gastric Cancer
  • HER2-positive Gastroesophageal Junction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
260 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Real-world Time to Treatment Failure (rwTTF) [ Time Frame: 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 ]

Central Contacts

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