NCT06764355

Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma

Total Neoadjuvant Therapy With Induction Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis. Collectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.

Conditions

• ESCC
• Total Neoadjuvant Treatment
• Pathological Complete Response

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg, 1h-IVF, Q3W on day 1 for 2 cycles
DRUG	Paclitaxel	Paclitaxel 175 mg/m2, 3h-IVF, Q3W on day 1 for 2 cycles
DRUG	Cisplatin	Cisplatin 75 mg/m2, 2h-IVF, Q3W on day 1 for 2 cycles
RADIATION	Chemoradiotherapy	Chemoradiotherapy * Paclitaxel 50 mg/m2, 1h-IVF, on days 1, 8,15, 22, and 29; * Cisplatin 30 mg/m2,1h-IVF, on days 1, 8,15, 22, and 29; * RT: 1.8 Gy/fraction, 5 days a week, for 25 fractions (total dose= 45 Gy).

Timeline

• Start date: 2025-07-23
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-01-08
• Last updated: 2026-01-27

Locations

1 site across 1 country: Taiwan