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)
Shanghai Chest Hospital
52 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
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Interventions
Sintilimab 200mg iv Q3W
Liposomal paclitaxel: 150mg/m2, Q3W + cisplatin: 75mg/m2, Q3W (combined with PD-1 therapy) Liposomal paclitaxel: 50mg/m2, Q3W + cisplatin: 20mg/m2, Q3W (combined with radiotherapy )
The total dose is 5040cCy in 28 fractions (5 days per week, 1.8 Gy/day).
Locations(1)
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NCT06709417