OncoMatch/Clinical Trials/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)
Is NCT06709417 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Chemotherapy for esophageal squamous cell carcinoma (escc).
Treatment: Sintilimab · Chemotherapy — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage CT4BN-/+M0, CTANYN+M0 (clinical)
Excluded: Stage DISTANT METASTASES
clinical staging of cT4bN-/+M0 and/or cTanyN+M0 (extracapsular invasion of mediastinal lymph nodes). Primary lesion is inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1, anti-PD-L1, or any other agents targeting stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
Cannot have received: chemotherapy
No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Cannot have received: radiation therapy
No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Cannot have received: targeted therapy
No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Cannot have received: immunotherapy
No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Lab requirements
Blood counts
Adequate organ function required; no surgical contraindications based on preoperative evaluation of organ function.
Kidney function
Adequate organ function required; no surgical contraindications based on preoperative evaluation of organ function.
Liver function
Adequate organ function required; no surgical contraindications based on preoperative evaluation of organ function.
Adequate organ function. No surgical contraindications based on preoperative evaluation of organ function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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