Study for Metastatic Foregut Adenocarcinoma with Undetectable ctDNA
This study is for patients aged 18-80 with metastatic foregut adenocarcinoma (cancers of the esophagus, stomach, or pancreas) whose circulating tumor DNA (ctDNA) levels are undetectable after initial chemotherapy. You would be randomly assigned to either receive standard care or standard care plus a "sequential cytoreductive intervention." This intervention involves multiple procedures to remove cancerous tumors, depending on where the cancer has spread. Researchers will use the Signatera Genome ultra-sensitive ctDNA blood test to check for remaining cancer cells. The main goal is to see if adding the sequential cytoreductive intervention helps patients live longer without their cancer growing or spreading, measured for up to 12 months after starting the study. The study plans to enroll 54 participants, but its current status is unclear.
- Study design
- This is a randomized, open-label, single-center Phase 2 study comparing two treatment approaches in about 54 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for progression-free survival for up to 12 months after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Recruiting
PHASE2Ages 18–80InterventionalTreatmentYale UniversityInvestigator-initiated
~54 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Sequential cytoreductive interventionSignatera Genome ultra-sensitive ctDNA blood test
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Progression Free Survival (PFS)
Measured over up to 12 months post-randomization
Conditions
Where it's being run
1 sites across 1 statesConnecticut1
Study leadership
- Kiran Turaga, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.
Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo/radioembolization (cholangiocarcinomas).
Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:
Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.
Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.
Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.
Patients must have at least 4 months of prior effective systemic therapy.
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.
Patient who is at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.
Has an ECOG performance status score 0-1 (see Appendix 6) at the time of randomization.
A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.
A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence) during the treatment period and for at least 95 days following completion. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the participant may participate in the main study without participating in the FBR.
Has a primary tumor that is not amenable to the treatment modalities listed in section 3.
Has albumin level less than 3.0 g/dL despite appropriate nutritional support. Diagnostic Assessments
Has detectable ctDNA at the time of enrollment.
Has an active infection requiring systemic therapy.
Has known active TB/COVID infection.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.
Inability to receive chemotherapy and/or surgery and/or radiotherapy and/or ablative procedures due to medical/insurance reasons.
Requires emergency surgery due to bleeding, perforation, or obstruction.
Exclusion
Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has hypoxia as defined by pulse oximeter reading \<92% at rest or requires intermittent or chronic supplemental oxygen.
Has developed progressive disease on current line of systemic therapy.
Has a known additional malignancy that is progressing or has required active treatment within the past three years.
Has known CNS metastasis and/or carcinomatous meningitis.
Has known osseous metastasis.
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. Medially controlled arrhythmia stable on medication is permitted.
Has poorly controlled hypertension defined as SBP ≥150mmHg and/or DBP ≥90mmHg.
Has moderate to severe hepatic impairment (Child-Pugh B or C).
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).
Has known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.
What this trial measures
- Number of participants with Progression Free Survival (PFS)up to 12 months post-randomization
PFS is defined as the time from randomization to first documented disease progression by Resist 1.1 criteria or death from any cause, whichever occurs first.