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Tislelizumab + Chemoradiotherapy in Stage IVb ESCC
NCT05547828Phase 2
Key facts
- Status
- Unknown
- Start
- Dec 2022
- Primary completion
- Dec 2024
- Sponsor
- Xinxiang Medical University First Affiliated Hospital
- Modality
- Monoclonal Antibodies
- Drugs
- tislelizumab
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
01
Overview
Phase 2, open-label, single-arm trial of tislelizumab in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Xinxiang Medical University First Affiliated Hospital. Primary endpoint: Objective Response Rate up to 24 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Tislelizumab + Chemoradiotherapy
Tislelizumab + Nab-paclitaxel + Radiotherapy
03
Who it enrols
Patients with stage IVb esophageal squamous cell carcinoma, no prior anti-tumor treatment, ECOG PS 0-1, and adequate organ function.
04
Endpoints
Primary
Objective Response Rate
Secondary
Disease Control Rate
Progression Free Survival
Overall Survival
Drug-Related Safety Indicators
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