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NeoART – A phase Ib/II platform trial evaluating the safety and activity of neoadjuvant trastuzumab-deruxtecan containing combination therapies for HER2+, resectable esophagogastric adenocarcinoma

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518841-12-00
Acronym
NeoART
Enrollment
39
Registered
2025-01-31
Start date
2025-03-25
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 positive resectable esophagogastric adenocarcinoma

Brief summary

Feasibility rate, defined as proportion of patients receiving the protocol treatment according to the planned schedule before surgery without occurrence of at least one dose-limiting toxicity (DLT)

Detailed description

Assessment of safety of the treatment as determined by the incidence, type, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0, Perioperative morbidity (Clavien-Dindo classification) and mortality, Pathological complete remission (pCR) rate by local assessment corresponding to the ypT0 ypN0 stage category, R0 resection rate

Interventions

Sponsors

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Feasibility rate, defined as proportion of patients receiving the protocol treatment according to the planned schedule before surgery without occurrence of at least one dose-limiting toxicity (DLT)

Secondary

MeasureTime frame
Assessment of safety of the treatment as determined by the incidence, type, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0, Perioperative morbidity (Clavien-Dindo classification) and mortality, Pathological complete remission (pCR) rate by local assessment corresponding to the ypT0 ypN0 stage category, R0 resection rate

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026