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Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Recruiting
18-70 years
All
Phase 2

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Overview

The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.

Eligibility

Inclusion Criteria:

  • Age 18-70, male and female.
  • Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.
  • No previous anti-tumor treatment.
  • ECOG score was 0-1.
  • Expected survival of ≥ 6 months
  • Adequate organ reserve function.

Exclusion Criteria:

  • Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.
  • Known Her-2 positive( IHC 3+ or FISH positve).
  • Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody
  • Severe allergic reaction to monoclonal antibody.
  • Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study
  • Known endoscopic signs of active bleeding from the lesion

Study details
    PD-1
    Neoadjuvant Chemoradiotherapy
    Gastroesophageal Junction Cancer

NCT06250894

Wuhan Union Hospital, China

16 February 2024

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