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ILDR Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma
NCT07339488Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2025
- Primary completion
- Oct 2029
- Countries
- 1
- 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). Primary endpoint: 1-Year Progression-Free Survival Rate. Started Dec 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
ILDR plus immunochemotherapy plus surgery
1Gy/1F ILDR + albumin-bound paclitaxel (3 cycles of 260 mg/m2 on day 1), cisplatin (3 cycles of 75 mg/m2 on day 1), and tislelizumab (3 cycles of 200 mg on day 1) + surgery
03
Who it enrols
Adults aged 18-75 with borderline resectable or unresectable thoracic esophageal squamous cell carcinoma, ECOG 0-1, adequate organ function, and no prior anti-tumor treatment.
04
Endpoints
Primary
1-Year Progression-Free Survival Rate
Secondary
Pathological Complete Response Rate
Objective Response Rate
Major Pathological Response Rate
Disease Control Rate
Adverse Event Incidence Rate
1-Year Overall Survival Rate
Surgical Conversion Rate
R0 Resection Rate
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