drugset / Trial / NCT04989985

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

NCT04989985

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-09-01
Primary completion
2024-08-01
Completion
2027-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Comparator Oxaliplatin Small molecule 130 mg/m2 Intravenous
Comparator S-1 Small molecule 40 mg
Comparator S-1 Small molecule 60 mg