Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma
Austria, Germany36 participantsStarted 2025-03-25
Plain-language summary
The study is a phase Ib/II, prospective, single arm, open label, non-randomized, multi-center platform trial assessing the feasibility and safety of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient\* has given written informed consent.
✓. Patient is ≥ 18 years of age at time of signing the written informed consent.
✓. Patient has histologically proven locally advanced (cT2-4, any cN, M0 OR any cT, cN+, M0 stage) gastric, esophagogastric junction or lower esophageal adenocarcinoma that:
✓. Is considered technically resectable
✓. Does not involve distant site of the peritoneal cavity
✓. Patient has a HER2 positive tumor (by local testing) defined by HER2 IHC 3+ or IHC 2+ plus ISH positive with a HER2:CEP17 ratio of ≥ 2 according to classically used criteria for defining HER2 positivity \[Lordick et al. 2017\] .
✓. Patient has a ECOG performance status 0 or 1.
✓. Patient has adequate blood count, liver-enzymes, and renal function:
Exclusion criteria
✕. Patient received previous (radio)chemotherapy or HER2-targeted therapy for the same condition or within the past five years for any other cancerous condition.
✕. Patient received prior partial or complete esophagogastric tumor resection.
✕. Patient has known hypersensitivity to any component of the T-DXd formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the study drugs.
What they're measuring
1
Feasibility rate
Timeframe: 9 weeks
Trial details
NCT IDNCT06731803
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Patient has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
✕. Patient has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.).
✕. Patient received a prior complete pneumonectomy
✕. Patient has inadequate cardiac function (LVEF value \< 50 %) as determined by echocardiography.
✕. Patient has a known complete absence of dihydropyrimidine dehydrogenase (DPD) activity