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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma

Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma: A Randomized Prospective Clinical Study (OMEC-5)

Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma (NCT07000253) is a Phase 2 / Phase 3 interventional studying Esophageal Cancer and Gastric (Stomach) Cancer, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Purpose of the Study: This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases. Background: In about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this and identify potential biomarkers for treatment response. Study Design: Initiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe. Total of 414 patients to be enrolled. Duration: \~53 months (35 months enrollment + 18 months follow-up). Approved by the medical ethics committee at Amsterdam UMC. Procedure: Eligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel. Initial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and/or targeted therapy depending on tumor markers like HER2 or Claudin 18.2). Response assessment (Review 1): Imaging and/or laparoscopic examination. If oligometastases persist and tumors have not progressed, participants are randomized into two groups: Group A (longer systemic therapy): 4 more months of systemic therapy, then local treatment if disease is stable, followed by 4 months of immunotherapy ± targeted therapy. Group B (shorter systemic therapy): Immediate local treatment followed by 4 months of systemic therapy, then reassessment and potentially 4 months of immunotherapy ± targeted therapy. Follow-up: Regular scans and quality-of-life questionnaires (5 times), and periodic blood sampling (4 times). Treatments Involved: Chemotherapy: CapOx or FOLFOX Immunotherapy: nivolumab or pembrolizumab Targeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive) Potential Benefits and Risks: Patients may benefit from better disease control and a personalized treatment strategy. Known side effects relate to the standard treatments used (chemo, immuno, targeted therapies), and no extra medical risk is expected beyond routine care. Possible inconveniences include blood draws, scans, minor surgery (laparoscopy), and time investment. Data and Sample Handling: Personal data and tumor/blood samples are coded and securely stored. Data may be used for future cancer research if the patient consents. Participants can withdraw at any time. Confidentiality and Privacy: Patient data are kept confidential, and participants have rights to access or delete their data. Privacy measures comply with GDPR and Dutch law. Compensation and Insurance: Participation is voluntary, with no financial compensation. Standard treatment costs are covered by healthcare insurance. No extra insurance is required, as the treatment aligns with standard care practices.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 290 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years - Ability to provide written willing to sign a consent form - diagnosed by tissue sample (biopsy-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 previous cancer treatment that works throughout the body (like chemotherapy) 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. Who Should NOT Join This Trial: - Squamous cell carcinoma - Brain metastases - Peritoneal or pleural carcinomatosis - Patients with MSI dMMR - Uncontrolled weakened immune system (e.g. AIDS) - Peripheral neuropathy \>CTCAE grade 1, precluding start of full dose oxaliplatin treatment - Both organ metastasis and extra-regional lymph node metastasis ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Chemotherapy

Chemotherapy preferably CapOx (capecitabine + oxaliplatin) or FOLFOX (5-fluoruracil, leucovorin and oxaliplatin) will be combined with immunotherapy (preferably nivolumab or pembrolizumab) and/or targeted therapy (for example trastuzumab in the case of HER2 overexpression or zolbetuximab in the case of Claudin 18.2 overexpression). These regiments are the standard-of-care (SOC) combination therapies used in this study. Acceptable chemotherapy regimens predominantly for Asian centers include SOX (S-1 and Oxaliplatin).

DRUG

Targeted Systemic Therapy

Biomarker selected patients will receive trastuzumab, zolbetuximab or any other targeted agent according to standard of care.

DRUG

Immunotherapy

Biomarker selected patients will recieve checkpoint inhibitors according to standard care

PROCEDURE

Surgery

If the primary tumor is present, this tumor will be surgically removed. Metastases may also be removed by surgery.

RADIATION

Radiotherapy

Metastases may be irradiated

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Amsterdam University Medical Center
Amsterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07000253), the sponsor (Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07000253 clinical trial studying?

Purpose of the Study: This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases. Background: In about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemi… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07000253?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07000253?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07000253. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07000253. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.