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NCT06059495
DEWI: Watch-and-Wait With Dostarlimab in Localized dMMR/MSI-H Gastric/GEJ Adenocarcinoma Phase II Study
Conditions: Adenocarcinoma - GEJ, Gastric Adenocarcinoma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 89
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Location: Besancon University Hospital Center Besançon
Summary
This phase II study evaluates dostarlimab followed by a watch-and-wait strategy in patients with localized dMMR/MSI-H gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study aims to determine whether surgery can be safely avoided in patients achieving a complete response, defined by negative endoscopy and tumor-free biopsies after treatment.
Eligibility Criteria
Inclusion and exclusion criteria are identical in both cohorts, except for inclusion criteria 3 and 4.
Inclusion criteria
The patient is eligible to be included in the study only if all the following criteria apply:
1. Is capable of giving signed and dated informed consent,
2. Has an ECOG PS of 0-1,
3. Age ≥18 years old:
* A patient over 70 years of age is eligible to participate in the main initial cohort if the patient respects all the criteria and has a score G8 of ≥14.
* A patient over 70 years with a score G8 \
Source: ClinicalTrials.gov (NCT06059495). StuddyBuddy aggregates publicly available trial information.