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Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma

RecruitingNAAges 18 Years - 80 YearsAllThe Second Hospital of Shandong University
NCT07430579 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

This study is a prospective, single-arm, phase II exploratory clinical trial. The primary endpoint of this study is to evaluate the pathological complete response (pCR) rate after surgery and to assess the safety of neoadjuvant therapy with adebrelimab combined with platinum-based chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) at the Second Qilu Hospital of Shandong University. The primary endpoint of this clinical trial is the pathological complete response (pCR) rate, defined as the absence of residual viable tumor cells in the resected specimen, including lymph nodes (ypT0N0M0). Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs), as well as quality of life (QOL) assessments during neoadjuvant immuno

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients must have a histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma ๏ผˆESCC๏ผ‰. 2. Eligible patients are those with stage II/III disease according to the AJCC/UICC 8th edition Tumor-Node-Metastasis (TNM) staging system, presenting with cT1-3N1-2M0 or cT3-4aN0M0 disease. 3. Patients could tolerate chemotherapy and surgery after evaluation and MDT discussion, accepting the clinical trial protocol. Exclusion Criteria: 1. Patients with a history of other uncured malignancies within the past 5 years, individuals with ongoing or a history of autoimmune diseases, and those who have received any prior anti-tumor therapy. 2. Patients' cardio- pulmonary function could not tolerate surgery or chemotherapy, or don't accept the clinical trial protocol.
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What it tests

  • adebrelimab combined with chemotherapy
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Where

1 site
The Second Qilu Hospital of Shandong University
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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