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NCT06814158PHASE2NOT_YET_RECRUITING

Neoadjuvant Ivonescimab and Chemotherapy in Resectable Esophageal Cancer

A Phase II Study of Neoadjuvant Ivonescimab Combined with Chemotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor: Tianjin Medical University Cancer Institute and Hospital

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Key Facts

Study type
INTERVENTIONAL
Conditions
Esophageal Squamour Cell Cancer
Interventions
Ivonescimab Combined With Chemotherapy
Enrollment
57 participants
Primary completion
Jul 2026
Study completion
Dec 2026
First posted
Feb 2025
Last updated
Feb 2025

Primary Endpoints (CT.gov)

pathological complete response, pCR

Time frame: From enrollment to the postoperative pathology report at 6 weeks

Eligibility Criteria

Inclusion Criteria: * 1\) Histologically confirmed primary esophageal squamous cell carcinoma, locally advanced, staging cT1N2M0, cT2-3N0-2M0 (stage II/III), AJCC 8th edition clinical staging of esophageal squamous cell carcinoma; 2) Surgical treatment is possible; 3) ECOG score: 0 to 1; 4) The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): the subject has no dysfunction of major organs, and the blood routine, lung, liver, kidney function, and heart function are basically normal. Laboratory laboratory test indicators must meet the following requirements: blood: white blood cells\>4.0 × 109/L, absolute count of neutrophils (ANC) ≥ 2.0 × 109/L, platelet count\>100 × 109/L, hemoglobin\>90g/L; Pulmonary function: FEV1 ≥ 1.2L, FEV1% ≥ 50%, and DLCO ≥ 50%; Liver function: serum bilirubin is below 1.5 times the maximum normal value; ALT and AST are 1.5 times lower than the maximum normal values

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov