Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy

Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy.

Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy (NCT06687876) is a Phase 2 interventional studying Oesophageal Adenocarcinoma and Tumor Microenvironment, sponsored by Amsterdam UMC, location VUmc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The primary objective of this study is to investigate whether two weeks of metformin treatment can activate the tumour microenvironment in patients with stage II and III oesophageal adenocarcinomas.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Oesophageal Adenocarcinoma 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.

With a target enrollment of 14 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Surgical resectable (\<T4b, N0 or N+, M0), and histologically proven adenocarcinoma of the oesophagus or gastro-oesophageal junction planning to undergo neoadjuvant chemoradiotherapy. - Adult patients (age ≥ 18 years). - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 (cf. Appendix A). - Adequate hematological, renal and hepatic functions defined as: - Absolute Neutrophil Count ≥ 1.5 x 10\^9/L - platelet count at least 100 x 10\^9/L - blood count (hemoglobin) at least 5.6 mmol - Total bilirubin ≤ 1.5 x upper normal limit - Creatinine clearance (Cockroft) \> 30 ml/min - Patients must be willing to undergo two endoscopies for investigational purposes. - Written, voluntary willing to sign a consent form. - Patients must be accessible to follow up and management in the treatment center. Who Should NOT Join This Trial: - Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs. - Patients prescribed metformin or another anti-diabetic drug for any reason. - Patients allergic or intolerant to metformin. - Excessive alcohol consumption. - Use of OCT1/OCT2 inhibitors (e.g. verapamil, cimetidine, dolutegravir, isavuonazol, trimethoprim, vandetanib, crizotinib and Olaparib). - Use of OCT1/OCT2 inducers (e.g. rifampicine). - Use of immunosuppressive medication (corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, cyclophosphamide). - Previous systemic therapy or radiotherapy on the oesophagus. - Severe renal impairment (CLcr ≤ 30 ml/min). - Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of oesophageal cancer. - Previous systemic therapy for other forms of cancer within the last six months. - Patients with prior allogeneic stem cell or solid organ transplantation - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. ...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: * Surgical resectable (\<T4b, N0 or N+, M0), and histologically proven adenocarcinoma of the oesophagus or gastro-oesophageal junction planning to undergo neoadjuvant chemoradiotherapy. * Adult patients (age ≥ 18 years). * ECOG performance status 0 or 1 (cf. Appendix A). * Adequate hematological, renal and hepatic functions defined as: * Absolute Neutrophil Count ≥ 1.5 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Hemoglobin ≥ 5.6 mmol * Total bilirubin ≤ 1.5 x upper normal limit * Creatinine clearance (Cockroft) \> 30 ml/min * Patients must be willing to undergo two endoscopies for investigational purposes. * Written, voluntary informed consent. * Patients must be accessible to follow up and management in the treatment center. Exclusion Criteria: * Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs. * Patients prescribed metformin or another anti-diabetic drug for any reason. * Patients allergic or intolerant to metformin. * Excessive alcohol consumption. * Use of OCT1/OCT2 inhibitors (e.g. verapamil, cimetidine, dolutegravir, isavuonazol, trimethoprim, vandetanib, crizotinib and Olaparib). * Use of OCT1/OCT2 inducers (e.g. rifampicine). * Use of immunosuppressive medication (corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, cyclophosphamide). * Previous systemic therapy or radiotherapy on the oesophagus. * Severe renal impairment (CLcr ≤ 30 ml/min). * Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of oesophageal cancer. * Previous systemic therapy for other forms of cancer within the last six months. * Patients with prior allogeneic stem cell or solid organ transplantation * Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery. * Pulmonary fibrosis, active, non-infectious pneumonitis and/or severely impaired lung function precluding major surgery and/or radiation. * Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine. * Dementia or altered mental status that would prohibit the understanding and giving of informed consent.

Treatments Being Tested

DRUG

Metformin

Twice a day 500mg of metfomrin orally (1000mg/day) during a 2-week period.

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 UMC

Amsterdam, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06687876), the sponsor (Amsterdam UMC, location VUmc), 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 NCT06687876 clinical trial studying?

The primary objective of this study is to investigate whether two weeks of metformin treatment can activate the tumour microenvironment in patients with stage II and III oesophageal adenocarcinomas. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06687876?

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 NCT06687876?

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 NCT06687876. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06687876. 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 2026-06-26 · Data from ClinicalTrials.gov.