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Sintilimab with Chemotherapy and PEG-rhG-GSF for Neoadjuvant Esophageal Squamous Cell Carcinoma
NCT06563869Phase 3
Key facts
- Status
- Recruiting
- Start
- Feb 2024
- Primary completion
- Nov 2025
- Countries
- 1
- Sponsor
- Jiangsu Provincial People's Hospital
- Modality
- Monoclonal Antibodies
- Drugs
- sintilimab
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
01
Overview
Phase 3, open-label, single-arm trial of sintilimab in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Jiangsu Provincial People's Hospital. Primary endpoint: Pathologic Complete Response. Started Feb 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Neoadjuvant patients
Sintilimab + Platinum-based Chemotherapy + PEG-rhG-GSF followed by surgery
03
Endpoints
Primary
Pathologic Complete Response
Secondary
Major Pathologic Response
Recurrence-Free Survival
R0 Resection Rate
Adverse Events
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