Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
| HER2-positive Gastroesophageal Junction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2-positive gastric/gastroesophageal junction adenocarcinoma
- description
- 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.
- interventionNames
- Drug: Trastuzumab deruxtecan (T-DXd)
Primary outcomes (1)
- measure
- 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
- description
- rwTTF is defined as time from T-DXd treatment initiation date to the earliest date of treatment discontinuation due to disease progression, physician decision, adverse events or death.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available