OncoMatch/Clinical Trials/NCT07039162
Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma
Is NCT07039162 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and Paclitaxel for esophageal squamous cell carcinoma (escc).
Treatment: Tislelizumab · Paclitaxel · Cisplatin — This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery. The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage M1LYM
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Patient has received systemic therapy for advanced ESCC
Cannot have received: T-cell costimulating or immune-checkpoint pathway therapy
Previous therapy targeting T-cell costimulating or immune-checkpoint pathways
Lab requirements
Blood counts
WBC ≥3,500/mm3; Hemoglobin ≥ 9.0 g/dL; Platelet ≥ 80,000/mm3
Kidney function
Creatinine clearance ≥50 ml/min (24h urine or Cockroft-Gault formula)
Liver function
Total bilirubin ≤ 2-fold ULN; ALT and AST ≤ 5-fold ULN AND ≤200 U/L; Albumin ≥2.5 g/dL; PT, aPTT and INR ≤1.5-fold ULN
Adequate major organ functions: WBC ≥3,500/mm3; Hemoglobin ≥ 9.0 g/dL; Platelet ≥ 80,000/mm3; Total bilirubin ≤ 2-fold ULN; ALT and AST ≤ 5-fold ULN AND ≤200 U/L; PT, aPTT and INR ≤1.5-fold ULN; Albumin ≥2.5 g/dL; Creatinine clearance ≥50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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