Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence — VESTIGE  

Gastric and Esophagogastric Junction Adenocarcinoma Clinical Trial

Official title: Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study

Status Active, not recruiting

Clinical Trial Summary

The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection.

Other study objectives:

• To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study

• To correlate nutritional status assessment on outcomes and quality of life of patients

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Gastric and Esophagogastric Junction Adenocarcinoma
• Recurrence

• NCT number: NCT03443856
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 17, 2019
• Completion date: June 2026