drugset / Trial / NCT06709417

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)

NCT06709417 ↗

Phase 2 Recruiting 52 enrolled Shanghai Chest Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or cTanyN+M0 staging (including those with extracapsular invasion of mediastinal lymph nodes).

Timeline

Start
2024-11-01
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 —
Subject Paclitaxel Small molecule 50 mg/m2 —
Subject Sintilimab Monoclonal antibody 200 mg Intravenous