RecruitingPhase 2NCT06764355

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

Sponsor

National Taiwan University Hospital

Enrollment

50 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

ESCC Pathological Complete Response Total Neoadjuvant Treatment

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment strategy for locally advanced esophageal squamous cell carcinoma (a type of throat/food pipe cancer) that combines immunotherapy and chemotherapy before radiation and surgery. The goal is to shrink the tumor before removal to improve outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have squamous cell carcinoma of the chest portion of the esophagus confirmed by biopsy - Your cancer is locally advanced (spread to nearby lymph nodes or wall of the esophagus) but has not spread to distant organs - Your tumor length is ≤10 cm and width ≤5 cm - You have not had prior treatment for this cancer - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has grown into the airway (tracheobranchial tree) or caused a fistula - The tumor extends significantly into the stomach - Your cancer is adenocarcinoma (not squamous cell) - You are in poor health or have inadequate organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

200 mg, 1h-IVF, Q3W on day 1 for 2 cycles

DRUGPaclitaxel

Paclitaxel 175 mg/m2, 3h-IVF, Q3W on day 1 for 2 cycles

DRUGCisplatin

Cisplatin 75 mg/m2, 2h-IVF, Q3W on day 1 for 2 cycles

RADIATIONChemoradiotherapy

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).