NCT05170503

Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma

Neoadjuvant Sintilimab Plus SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: a Prospective, Single Arm Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Esophagogastric Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg iv drip. Qd D1 + Oxaliplatin 130/m2 iv drip. Qd D1 + Tegafur (Gimeracil and Oteracil Potassium Capsules) \[40mg/m2 if BSA \<1.25m2, 50mg/m2 if BSA ≥1.25m2 \& \<1.5m2, 60mg/m2 if BSA ≥1.5m2\] po. Bid D1-14 for three cycles

Timeline

• Start date: 2021-12-29
• Primary completion: 2026-01-01
• Completion: 2029-01-01
• First posted: 2021-12-28
• Last updated: 2025-06-12

Locations

1 site across 1 country: China