NCT07039162

Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma

Phase II Study of Tislelizumab Combined With Induction Chemoradiotherapy and Subsequent Conversion Surgery for Locally Advanced Unresectable ESCC

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Ming-Yu Lien · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)
• Locally Advanced Unresectable Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	1. ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. ) 3. Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.)
DRUG	Paclitaxel	1. ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (\* 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.)
DRUG	Cisplatin	1. ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )
RADIATION	Radiation Therapy	1\. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase.

Timeline

• Start date: 2025-09-26
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-06-26
• Last updated: 2026-02-27

Locations

8 sites across 1 country: Taiwan