Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study — DEWI  

Gastric Adenocarcinoma Clinical Trial

Official title: Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and/or Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

Status Recruiting

Clinical Trial Summary

This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)/microsatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma. The goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.

Clinical Trial Description

In patients with localized, resectable gastric or oeso-gastric junction (OGJ) adenocarcinoma radical surgery is the only curative option. Despite the evolution in treatment with multimodality strategies, gastric or OGJ adenocarcinoma remains one of the most lethal malignancies. When the disease is localized, perioperative chemotherapy with cytotoxic agents is the preferred strategy. The morbidity rate associated with oesophagogastrectomy/gastrectomy and their negative impact on patients' quality of life and considering the high efficacy of ICIs in patients with localized tumor, one might wonder whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma The purpose of this national, multicenter, open-label phase II study is to look at the effects of the immunotherapy drug dostarlimab with a watch-and-wait approach in patients with localized dMMR/MSI gastric or oeso-gastric junction adenocarcinoma and to determine whether patients with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approach can circumvent surgical resection. The primary objective of the study is the rate of complete clinical response at 1 year. A total of 59 patients are expected to be enrolled in the study. Patients will be included in participating centers, which will perform treatments. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma - GEJ
• Gastric Adenocarcinoma

• NCT number: NCT06059495
• Study type: Interventional
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: Marie-Line GARCIA LARNICOL, MD
• Phone: +33 (01) 40 20 85 00
• Email: gercor@gercor.com.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: December 18, 2023
• Completion date: September 1, 2028