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Tislelizumab sequential neoadjuvant therapy for locally advanced ESCC
NCT05189730Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2021
- Primary completion
- Jan 2025
- Countries
- 1
- Sponsor
- Sichuan Cancer 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 Sichuan Cancer Hospital. Primary endpoints: Complete Pathologic Response Rate at 3 months and Incidence of Adverse Events at 6 months. Started Jul 2021; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Total neoadjuvant therapy
Response-adapted neoadjuvant therapy starting with chemoradiotherapy, followed by potential immunochemotherapy intensification and adjuvant immunotherapy.
03
Who it enrols
Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma (T2N0-1M0, T3N0M0, T3N1M0, T1-3N2M0) suitable for surgery, ECOG 0-1, and adequate organ function. Excludes prior anti-cancer therapy, distant metastasis, active autoimmune disease, and immunodeficiency.
04
Endpoints
Primary
Complete Pathologic Response Rate
Incidence of Adverse Events
Secondary
Clinical Complete Remission
Major Pathological Remission Rate
Objective Remission Rate
Rate of R0 Resection
Events Free Survival
Overall Survival
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