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Disitamab vedotin + Sintilimab + XELOX in locally advanced gastric cancer
NCT06227325Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2024
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Henan Cancer Hospital
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)
- Drugs
- disitamab vedotin
- Conditions
- gastric cancer (GC)gastroesophageal junction adenocarcinoma
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Overview
Phase 2, open-label, single-arm trial of disitamab vedotin in gastric cancer (GC) and gastroesophageal junction adenocarcinoma, sponsored by Henan Cancer Hospital. Primary endpoint: Pathological Complete Response Rate at 12 weeks. Planned start Feb 2024; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment Group
RC48 + Sintilimab + XELOX
03
Who it enrols
Patients with locally advanced (cT3-4aN1-3M0) gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression (IHC 2+ or 3+) who have not received prior systemic treatment.
04
Endpoints
Primary
Pathological Complete Response Rate
Secondary
R0 Resection Rate
Disease Free Survival
Major Pathological Response Rate
Clinical Downgrading Rate
Overall Survival
Adverse Events
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