OncoMatch/Clinical Trials/NCT05495152
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
Is NCT05495152 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Sintilimab for esophageal squamous cell carcinoma.
Treatment: Sintilimab — No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage CT1-4AN+M0, T3-4AN0M0, CT1-2N0M0 AND PATHOLOGICALLY PROVEN T1-2N+M0
Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery. Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy plus surgery — neoadjuvant
residue disease is found after neoadjuvant chemotherapy plus surgery
Must have received: upfront surgery — upfront
cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery
Cannot have received: neoadjuvant chemoradiation therapy
Patients receive neoadjuvant chemoradiation therapy
Cannot have received: immunotherapy
Patients ever received immunotherapy
Lab requirements
Blood counts
white blood cell count ≥ 4×10^9/L; ANC ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; haemoglobin ≥ 9 g/dl
Kidney function
glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula
Liver function
serum bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.0 × ULN (ULN as per institutional standard)
Adequate bone marrow function: white blood cell count ≥ 4×10^9/L; absolute neutrophil count (ANC) ≥ 1.5×10^9/l; platelets ≥ 100×10^9/L; haemoglobin ≥ 9 g/dl. Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard). Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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