Blood test may let some stomach cancer patients skip harsh chemo
NCT ID NCT07565857
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a personalized blood test (Signatera) can identify gastric cancer patients who, after surgery, have no detectable cancer DNA and can safely receive a milder immunotherapy (durvalumab) instead of standard chemotherapy. About 1000 adults with stage II-IVa gastric cancer will be enrolled. The goal is to see if this approach maintains similar cancer-free survival while reducing treatment side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Signatera blood test (ctDNA monitoring) and durvalumab (immunotherapy)
- What this could lead to
- If successful, this could show that some patients with gastric cancer can safely skip intensive chemotherapy after surgery, reducing side effects while maintaining similar outcomes.
- What could go wrong
- This is an early-stage study (Phase NA) with 1000 participants, and the approach may not prove non-inferior to standard care. The blood test may miss some recurrences, and durvalumab has its own risks like immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed and dated informed consent form (ICF) obtained prior to any trial-specific enrollment procedure. 2. Age is ≥ 18 years-old at the time of ICF signature. 3. Able to submit adequate archival tumor tissue (eg, 6 to 10 unstained slides at 10 microns (μm) each or 12-19 unstained slides at 5-microns (μm) plus one hematoxylin and eosin slide (see study lab manual) obtained per standard of care procedures for submission to a central laboratory for Signatera testing OR prior commercial Signatera Genome test results. 4. Histologically confirmed adenocarcinoma of the stomach, esophagus and/or gastroesophageal junction (GEJ), resectable clinical Stage II-IVa per AJCC 9th edition. 5. Completion of full or modified course (based on Dosing and Modification Guidelines) of neoadjuvant D-FLOT therapy (ie, two 4-week cycles of durvalumab, four 2-week cycles of FLOT) . 6. Has undergone complete surgical resection of the gastric/GEJ tumor with pathologically confirmed negative margins (R0 resection). 7. Eligible to receive adjuvant D-FLOT treatment within 12 weeks postoperative per standard of care (SOC) as assessed by the treating clinician. 8. Known statuses pertaining to randomization stratification factors: 1. Post neoadjuvant, post-operative (yp) lymph node status and tumor staging (ypT1-3, N0 vs T4 or N+) 2. Combined Positive Score ( ≥ 1 vs \<1)Tumor PD-L1 status confirmed by immunohistochemistry/CPS score. 3. Post neoadjuvant, post-operative major pathological response (MPR): Yes/No 9. ECOG performance status 0-1. 10. No evidence of disease by radiographic imaging. 11. Must be willing to and able to comply with adjuvant treatment plans based on ctDNA results and other trial-mandated procedures. 12. Women of child bearing potential must have a confirmed negative pregnancy test within 14 days of enrollment per institutional standards. Exclusion Criteria: 1. Histologic presence of adenosquamous cell carcinoma, squamous cell carcinoma, gastrointestinal stromal tumor, or neuroendocrine tumors. 2. Radiographic evidence of unresectable metastatic disease (ie, IVb). 3. Presence of peritoneal dissemination. 4. Any prior therapy (eg, radiation, chemoradiation, chemotherapy) for gastric or gastroesophageal cancer other than neoadjuvant D-FLOT and R0 curative intent surgery. 5. Known contradiction or hypersensitivity to durvalumab per the prescribing information; known contraindication or hypersensitivity to Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel or any of the drug excipients. 6. Known history of active primary immunodeficiency (eg, HIV), other contraindications of immunotherapy or receiving immunosuppressive medication per approved label. 7. Female participants who are pregnant or breastfeeding. 8. Concurrent enrollment in another clinical trial unless the study is observational, non-interventional. 9. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the primary 36-month monitoring period. 10. Concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Participants with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment. 11. Any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical trial or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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