Clinical Trial

S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma

Recruiting Phase 2

Record status

This record was last updated August 4, 2021 (before its estimated August 1, 2024 completion). Its status may not reflect the trial's current state.

Summary

For locally advanced adenocarcinoma of esophagogastric junction(AEG) (cT3-4aN+M0), neoadjuvant chemotherapy was improved to downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced AEG could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sintilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for several malignant tumors. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sintilimab in combination with perioperative chemotherapy in locally advanced AEG.

Trial Details

NCT Number	NCT04989985
Lead Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University Collaborators: Sun Yat-sen University
Conditions	Locally Advanced Gastroesophageal Junction Adenocarcinoma, Chemotherapy Effect
Enrollment	302 participants
Start Date	2021-09-01
Primary Completion	2024-08-01 (estimated)
Study Completion	2027-08-01 (estimated)
Updated on ClinicalTrials.gov	2021-08-04