New drug under Real-World watch for tough stomach cancer
NCT ID NCT05993234
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study follows about 257 adults with advanced HER2-positive stomach or gastroesophageal junction cancer who have already tried a trastuzumab-based treatment. Researchers will track how well the drug trastuzumab deruxtecan (T-DXd) works in everyday medical practice, including time to next treatment and safety events. The goal is to see if T-DXd helps control the disease in a real-world setting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 257 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients with advanced HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen in a real-world setting in Europe.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female adult patient (age ≥ 18 years) with HER2 + advanced gastric or GEJ adenocarcinoma who have received a prior trastuzumab based regimen * Histological or cytological confirmed diagnosis of advanced HER2 positive gastric cancer or GEJ * Documented HER2 + status (archival sample or recent sample prior 2L therapy) * Decision to newly initiate monotherapy T-DXd or conventional therapies per SMPC according to the physician's choice * Written dated and signed Informed Consent (ICF) to participate in the study Exclusion Criteria: * Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded * Pregnancy or breastfeeding No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AO "Cardinale Giovanni Panico"
Tricase, 73039, Italy
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AOU Careggi
Florence, 50134, Italy
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AOU Pisana - Stabilimento Santa Chiara
Pisa, 56126, Italy
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ARNAS Garibaldi - PO Nesima
Catania, 95122, Italy
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AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna
Ravenna, 48121, Italy
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Alb Fils Kliniken GmbH
Göppingen, 73035, Germany
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Antwerp University Hospital
Edegem, 2650, Belgium
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Azienda Ospedaliero-Universitaria di Modena
Modena, 41124, Italy
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CHU Helora Hospital de La Louvière - Site Jolimont
Haine-Saint-Paul, 7100, Belgium
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CaritasKlinikum Saarbrücken
Saarbrücken, 66113, Germany
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Charite Campus Benjamin Franklin
Berlin, 12203, Germany
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
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Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
Hanover, 30625, Germany
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Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
Hamburg, 20249, Germany
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IRCCS "S. De Bellis"
Castellana Grotte, 70013, Italy
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IRCCS AOU San Martino
Genova, 16132, Italy
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IRCCS Ospedale San Raffaele
Milan, 20132, Italy
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Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131, Italy
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JESSA Hasselt
Hasselt, 3500, Belgium
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KRH Klinikum Siloah
Hanover, 30459, Germany
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Kepler Universitätsklinikum
Wels, 4600, Austria
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Klinikum am Steinenberg Reutlingen
Reutlingen, 72764, Germany
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Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
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Krankenhaus St. Vinzenz in Zams
Zams, 6511, Austria
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Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700, Austria
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MV-Zentrum für Hämatologie & Onkologie
Cologne, 50677, Germany
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MVZ am Klinikum Aschaffenburg
Aschaffenburg, 63739, Germany
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Medizinische Universität Wien
Vienna, 1090, Austria
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OLV Hospital Aalst
Aalst, 9300, Belgium
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Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010, Austria
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Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
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Praxis Onkologie Rheinsieg
Troisdorf, 53840, Germany
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Studienzentrum am Raschplatz GbR
Hanover, 30161, Germany
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UZ Brussel
Jette, 3000, Belgium
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UZ Gent
Ghent, 9000, Belgium
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University Hospital Essen
Essen, 45147, Germany
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Università degli studi di Napoli Federico II
Naples, 80131, Italy
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Università della Campania 'Luigi Vanvitelli'
Naples, 80131, Italy
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Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug trio takes aim at HER2-Positive stomach cancer
- Two-Drug combo targets HER2-Positive stomach cancer after First-Line failure
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can an antibody boost chemotherapy to stop early stomach cancer from returning?
- Can a targeted cancer drug deliver in the real world?
- Promising combo for stomach cancer stalls: trial ends early