NCT06687876 Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy
| NCT ID | NCT06687876 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Oesophageal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-03-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 14 participants in total. It began in 2025-03-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Sarah Derks, MD PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT06687876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oesophageal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06687876 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06687876 currently recruiting?
Yes, NCT06687876 is actively recruiting participants. Contact the research team at c.brugman@amsterdamumc.nl for enrollment information.
Where is the NCT06687876 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Amsterdam, Netherlands.
Who is sponsoring the NCT06687876 clinical trial?
NCT06687876 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Sarah Derks, MD PhD at Amsterdam UMC, location VUmc. The trial plans to enroll 14 participants.