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OncoMatch/Clinical Trials/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

Is NCT07282912 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for foregut adenocarcinoma.

Phase 2RecruitingYale UniversityNCT07282912Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Gastric Cancer

Pancreatic Cancer

Cholangiocarcinoma

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: systemic therapy

Patients must have at least 4 months of prior effective systemic therapy.

Lab requirements

Blood counts

hemoglobin ≥ 8 g/dL; ANC ≥ 1500/uL; platelet count ≥ 75000/uL; albumin ≥ 3.0 g/dL

Kidney function

creatinine clearance ≥ 50 mL/min

Liver function

total bilirubin ≤ 1.5 times the upper limit of normal (ULN); AST & ALT ≤ 5 times ULN

Cardiac function

No clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.

Has hemoglobin ≥ 8 g/dL. Has ANC ≥ 1500/uL. Has platelet count ≥ 75000/uL. Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN). Has aspartate aminotransferase (AST) & alanine aminotransferase (ALT) ≤ 5 times ULN. Has creatinine clearance ≥ 50 mL/min. Has albumin level less than 3.0 g/dL despite appropriate nutritional support [excluded]. Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Smilow Cancer Center · New Haven, Connecticut

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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