PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)
Sun Yat-sen University
422 participants
Nov 1, 2022
INTERVENTIONAL
Conditions
Summary
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
Locations(1)
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NCT05357846