NCT07282912

Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.

Detailed description

Patients with oligometastatic foregut (esophagus, gastric, biliary, liver and pancreatic ) cancers derive benefit from surgical resection/ablation or radiation in selected patients. ctDNA is a liquid biopsy technique that has prognostic value in identifying patients that benefit from loco regional interventions (surgery/radiation/ablation). The primary objective of this study is to assess the Progression Free Survival (PFS) of patients with the addition of sequential cytoreductive intervention versus standard of care systemic therapy in patients with metastatic foregut adenocarcinoma and undetectable ctDNA after induction chemotherapy.

Conditions

• Foregut Adenocarcinoma
• Esophageal Adenocarcinoma
• Gastroesophageal Adenocarcinoma
• Gastric Adenocarcinoma
• Pancreas Adenocarcinoma
• Duodenal Adenocarcinoma
• Ampullary Adenocarcinoma
• Gallbladder Adenocarcinoma
• Intra - and Extrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Sequential cytoreductive intervention	A treatment plan that involves multiple procedures given one after another to remove cancerous tumors depending on metastasis.
DIAGNOSTIC_TEST	Signatera Genome ultra-sensitive ctDNA blood test	A personalized blood test that detects circulating tumor DNA (ctDNA) to monitor for molecular residual disease (MRD) in patients who have been diagnosed with cancer.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-12-15
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study