Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

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Description

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.

Study Overview

Start Date
March 30, 2021
Completion Date
March 30, 2025
Enrollment
32
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Min Jin
Wuhan, Hubei 430030, China

Eligibility

Minimum Age (years)
18
Maximum Age (years)
70
Eligibility Criteria
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 Contact Info

Study Contact Name
Min Jin
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06250894