Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Launched by WUHAN UNION HOSPITAL, CHINA · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced adenocarcinoma of the esophagogastric junction, which is a type of cancer that occurs where the esophagus meets the stomach. The trial is testing a combination of an immunotherapy drug called Sintilimab, along with chemotherapy and radiotherapy, to see how safe and effective this treatment is before surgery. The goal is to improve outcomes for patients who have not received any prior cancer treatments.

To participate in this trial, patients need to be between 18 and 70 years old and have a confirmed diagnosis of locally advanced esophagogastric junction adenocarcinoma. They should also be in relatively good health and expected to live for at least six more months. Participants can expect to receive the new treatment combination, and they will be closely monitored by healthcare professionals throughout the study. It's important to note that patients with other active cancers, certain health issues, or previous immunotherapy treatments may not be eligible to join. This trial is currently recruiting participants, so there’s an opportunity for eligible individuals to contribute to important cancer research.

Gender

ALL

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