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Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer
Sponsor: Natera, Inc.
Summary
The goal of this clinical trial is to assess if circulating tumor DNA, as assessed by Signatera tumor-informed MRD assay, can guide de-escalation of adjuvant therapy in patients with resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer. The main question it aims to answer is: • To demonstrate if 2-year disease-free survival (DFS) among participants with resectable clinical Stage II-IVa gastric/gastro-esophageal cancer who received neoadjuvant D-FLOT and are ctDNA negative after curative intent R0 surgery receiving adjuvant durvalumab monotherapy is non-inferior to standard of care D-FLOT. Researchers will compare post-operative ctDNA negative participants who are receiving adjuvant durvalumab monotherapy to those who receive standard of care (D-FLOT) to see if they have similar outcomes. Participants will be asked to: * Receive serial ctDNA testing * Visit their study doctor per their standard of care visits about every 3 months for first 2 years and then every 6 months for an additional 3 years * Answer 5 questionnaires about their well-being
Official title: SIGNAL GEC-101: Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-09
Completion Date
2034-09
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Signatera Genome ultra-sensitive ctDNA blood test
Signatera Genome is intended for use as a post-surgical risk stratification tool for patients with resectable clinical Stage II-IVa gastric/gastro-esophageal cancer who are ctDNA negative after R0 curative intent surgery. The test is used to identify patients with no evidence of MRD following definitive surgery.