OncoMatch/Clinical Trials/NCT06718205
Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma
Is NCT06718205 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nimotuzumab and Sintilimab for esophageal cancer.
Treatment: Nimotuzumab · Sintilimab · Paclitaxel-albumin · Cisplatin — This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: adjuvant therapy — adjuvant or radical treatment completed >6 months before recurrence
have received previous (new) adjuvant treatment / radical treatment regimen (including radical surgical resection and radical chemoradiotherapy regimen) after recurrence for more than 6 months
Cannot have received: anti-EGFR monoclonal antibody
Patients who have previously received treatment with anti EGFR monoclonal antibodies
Cannot have received: anti-PD-1 therapy
Patients who have previously received treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Cannot have received: anti-PD-L1 therapy
Patients who have previously received treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Cannot have received: anti-CTLA-4 therapy
Patients who have previously received treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Cannot have received: traditional Chinese medicine anti-tumor treatment (brucea, coix seed, polysaccharides from shiitake mushrooms, cantharides, toad skin, astragalus, Sophora flavescens, Polygonatum sibiricum, Hedyotis chinensis)
Exception: allowed if >2 weeks since last use
Patients who have received traditional Chinese medicine anti-tumor treatment within the past 2 weeks (including medicinal herbs such as brucea, coix seed, polysaccharides from shiitake mushrooms, cantharides, toad skin, astragalus, Sophora flavescens, Polygonatum sibiricum, and Hedyotis chinensis), but have been taking traditional Chinese medicine anti-tumor treatment for more than 2 weeks are allowed to be enrolled
Lab requirements
Blood counts
Hemoglobin ≥ 100 g/L; WBC ≥ 3.0×10^9/L; ANC ≥ 1.5×10^9/L; Platelets ≥ 75×10^9/L
Kidney function
Cr ≤ 1.5x ULN or creatinine clearance (CCr) ≥ 60 ml/min
Liver function
Total serum bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN if liver involvement)
Cardiac function
LVEF ≥ 50%; myocardial zymogram within normal range; INR or PT ≤ 1.5x ULN
Having adequate organ and bone marrow function, that is, meeting the following criteria: ... Hemoglobin content (HB): 100g / L; Leukocyte content (WBC) 3.0*10^9 / L; Neutrophil count (ANC) 1.5*10^9 / L; Platelet count (PLT) of 75*10^9 / L. ... Total serum bilirubin (TBIL) 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5ULN; ALT and LT AST 5 ULN; Cr≤1.5ULN Or creatinine clearance (CCr) 60 ml/min; ... INR or prothrombin time (PT) 1.5 times ULN; ... LVEF low normal value (50%); myocardial zymogram: within the normal range.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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