When to treat? new trial aims to optimize therapy for oligometastatic esophageal and gastric cancer
NCT ID NCT07000253
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This clinical trial is looking at the best timing for local treatments like surgery or radiation in people with esophageal or stomach cancer that has spread to only a few spots. All participants first get 4 months of standard drug therapy. Then, depending on their response, they are randomly assigned to either get local treatment right away or continue drugs for another 4 months before local treatment. The goal is to see which approach leads to better disease control and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chemotherapy (CapOx, FOLFOX, or SOX) combined with immunotherapy (nivolumab or pembrolizumab) and/or targeted therapy (trastuzumab or zolbetuximab)
- What this could lead to
- If successful, this could help doctors determine the best timing for local treatments like surgery or radiation, potentially improving disease control and survival for patients with limited metastatic cancer.
- What could go wrong
- This is a mid-stage trial with 290 participants, so results may not apply to all patients. The treatments have known side effects like fatigue and nausea, and the study may not show a clear benefit for one timing strategy over the other.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jan 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Age ≥18 years * Ability to provide written informed consent * Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement: * One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification) * ≤3 unilobar liver metastases or ≤2 bilobar liver metastases * ≤ 3 unilateral lung metastases * Unilateral adrenal gland involvement * Metastasis confined to 1 bone structure or 1 soft tissue compartment * Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable) * Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment * WHO performance status 0-2 * Indication for checkpoint inhibition and/or targeted therapy * PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use * HER2 overexpression as per local clinical practice for trastuzumab use * Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use. * Any other biomarker that allows targeted therapy in first line approved by EMA * No prior systemic therapy for metastatic disease * CT-scan ≤8 weeks prior to inclusion * Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment. Exclusion Criteria: * Squamous cell carcinoma * Brain metastases * Peritoneal or pleural carcinomatosis * Patients with MSI dMMR * Uncontrolled immunodeficiency (e.g. AIDS) * Peripheral neuropathy \>CTCAE grade 1, precluding start of full dose oxaliplatin treatment * Both organ metastasis and extra-regional lymph node metastasis * Conditions precluding local treatment or systemic therapy for oligometastatic disease: * Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis) * Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord * Simultaneous other malignancy or previous other malignancy with a disease-free period of \<5 years, except adequately treated non-melanoma skin cancer or in-situ cancers * Uncontrolled (bacterial) infections * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias * Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednisone * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * Pregnancy or breast feeding * Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
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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 places running it
5 sites in 3 countries. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Amsterdam University Medical Center
RECRUITINGAmsterdam, Netherlands
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Instituto de Investigación Sanitaria - INCLIVA
RECRUITINGValencia, Spain
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UMC Utrecht
NOT_YET_RECRUITINGUtrecht, Netherlands
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University of North Norway
RECRUITINGTromsø, Norway
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University of Oslo
RECRUITINGOslo, Norway
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