Actively Recruiting
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
Led by Yale University · Updated on 2026-03-04
54
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal, gastroesophageal, gastric, pancreatic, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder, duodenal, or ampullary adenocarcinoma.
- Primary tumor must be locally resectable or definitively treatable.
- Limited metastatic disease (up to 2 sites) that is completely resectable or treatable with curative intent.
- Patients with resected primary tumors and oligometastases at least 6 months after curative treatment may participate.
- Adequate organ function as outlined in screening labs within 30 days prior to intervention.
- Two concordant negative tissue-informed ctDNA tests at different times, with the second within 45 days before enrollment.
- At least 4 months of prior effective systemic therapy.
- Hemoglobin ≥ 8 g/dL.
- ANC ≥ 1500/uL.
- Platelet count ≥ 75000/uL.
- Total bilirubin ≤ 1.5 times the upper limit of normal.
- AST and ALT ≤ 5 times upper limit of normal.
- Creatinine clearance ≥ 50 mL/min.
- Age 18 to less than 81 years at informed consent.
- ECOG performance status 0-1 at randomization.
- Male participants must use contraception during treatment and for at least 95 days after.
- Female participants of childbearing age must not be pregnant or breastfeeding and must use contraception during treatment and for at least 95 days after.
- Provides written informed consent.
You will not qualify if you...
- Positive urine or serum pregnancy test within 3 days prior to randomization or treatment.
- Hypoxia with oxygen saturation below 92% at rest or requiring supplemental oxygen.
- Progressive disease on current systemic therapy.
- Additional malignancy requiring active treatment within past 3 years, except certain skin and in situ cancers.
- Known central nervous system metastasis or carcinomatous meningitis.
- Known bone metastasis.
- Clinically significant cardiac disease including unstable angina, recent myocardial infarction, or severe heart failure.
- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg).
- Moderate to severe liver impairment (Child-Pugh B or C).
- Psychiatric or substance abuse disorder interfering with study requirements.
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption.
- Known or previous malignant pleural effusion at enrollment.
- Histologic subtypes not included in inclusion criteria.
- Primary tumor not amenable to listed treatments.
- Albumin level less than 3.0 g/dL despite nutritional support.
- Detectable ctDNA at enrollment.
- Active infection requiring systemic therapy.
- Active tuberculosis or COVID infection.
- Immunodeficiency or recent immunosuppressive therapy.
- Pregnant, breastfeeding, or expecting to conceive or father children during study and 95 days after.
- Inability to receive chemotherapy, surgery, radiotherapy, or ablative procedures for medical or insurance reasons.
- Requires emergency surgery due to bleeding, perforation, or obstruction.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Smilow Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
W
Wumi Jemiseye, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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