A Phase 2 interventional study of Chemotherapy and Targeted Systemic Therapy in Esophageal Cancer, Gastric (Stomach) Cancer and Gastric Adenocarcinoma, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 2, Interventional, and Treatment
Among 17 studies in Esophageal Neoplasms by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — 5 open to participants now, 6 under way, 1 of them phase 3. Esophageal Neoplasms · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Among the 17 studies in Esophageal Neoplasms by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), this one is the 3rd largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2026, is one of 4 in phase 2, and was the 17th registered.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
Browse Esophageal Neoplasms studies →5 of the 17 studies in Esophageal Neoplasms by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) are open now, in 12 countries. Recruiting first, the newest first:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Ages 18+
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Ages 18+
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in United States, Brazil, Canada and 11 more countries
Ages 18+
By country, each count listing its studies:
Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 1 · Phase 4 1
First in 2010; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 290 is above the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Median enrollment 58 across the 14 interventional studies, 3,156 across the 3 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 181 are open to participants now.
1 of the studies in Esophageal Neoplasms by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05188313Phase 3Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer | 2027-07 |
Add it to your calendar (.ics) → With an account.
Among the 17 studies in Esophageal Neoplasms by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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 for exploratory research (if patients consent) 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:
Indication for checkpoint inhibition and/or targeted therapy
Exclusion Criteria:
Conditions precluding local treatment or systemic therapy for oligometastatic disease:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with no disease progression at 4 months (18 weeks) after systemic therapy with oxaliplatin, fluorpyrimidine, checkpoint inhibitor and/or taregted therapy and fit for local treatment will receive 4 additional months of systemic therapy and subsequent evaluation for local treatment to all disease sites.
Drug: Chemotherapy · Drug: Targeted Systemic Therapy · Drug: Immunotherapy · Procedure: Surgery · Radiation: Radiotherapy
Patients with no disease progression at 4 months (18 weeks) after systemic therapy oxaliplatin, fluorpyrimidine, checkpoint inhibitor and/or targeted therapy and fit for local treatment will recieve direct local treatment to all disease sites.
Drug: Chemotherapy · Drug: Targeted Systemic Therapy · Drug: Immunotherapy · Procedure: Surgery · Radiation: Radiotherapy
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).
Biomarker selected patients will receive trastuzumab, zolbetuximab or any other targeted agent according to standard of care.
Biomarker selected patients will recieve checkpoint inhibitors according to standard care
If the primary tumor is present, this tumor will be surgically removed. Metastases may also be removed by surgery.
Metastases may be irradiated
This study also gives Pembrolizumab, Trastuzumab, Nivolumab. No intervention listed here names it: that was found by reading the record.
progression free survival
the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation: * Disease progression (consisting of either progression in the number of metastases, recurrence at surgically treated metastasis, progression of ablated or irradiated metastasis, or recurrence of the primary tumor or regional lymph node metastasis) * Death due to any cause.
Time frame: the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation: Disease progression, death
Overall survival (OS)
Time frame: Interval between randomization and death or last follow-up up to 53 months after study initiation
2. Quality of Life (QoL)
Measured by the Summary Score of the EORTC QLQ-C30
Time frame: At 12 months after randomization.
Levels of ctDNA circulating in plasma
Time frame: before start of systemic treatment (t=0), at restaging (t=4 months) and during follow-up (at t= 6, t = 10 months and t = 12 months)
Potential new (blood or tissue based) biomarkers that predict clinical outcome and response to treatment
Time frame: before start of systemic treatment (t=0), at restaging (t=4 months) and during follow-up (at t= 6, t = 10 months and t = 12 months)
Plan to share: Undecided
Started Apr 2026 (actual). Primary completion is estimated for Nov 2031, 67 months after the start.
Of 174 non-industry phase 2 interventional studies under Esophageal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 85. This study's planned 67 months is above that.
Counting every sponsor, half of 198 studies reached it within 52 months; a quarter within 33 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
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