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Sintilimab and Radiotherapy With Immunonutrition Support in Esophageal Cancer
NCT06342167Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Modality
- Monoclonal Antibodies
- Drugs
- sintilimab
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
01
Overview
Phase 2, open-label, single-arm trial of sintilimab in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Primary endpoint: Progression-Free Survival Rate at 1 year. Started Mar 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Concurrent immunotherapy and radiotherapy
Sintilimab + radiotherapy + enteral nutritional emulsion (TPF-T)
03
Who it enrols
Adults with unresectable, locally advanced or early stage esophageal squamous cell carcinoma, PD-L1 positive, intolerant to synchronous chemoradiotherapy, no prior systemic therapy, ECOG 0-2, adequate organ function.
04
Endpoints
Primary
Progression-Free Survival Rate
Secondary
Objective Response Rate
Progression-Free Survival
Overall Survival Rate
Overall Survival
Incidence of Adverse Events
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