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MEtformin as a MEtabolic iNTervention in Oesophageal adenocarcinomas to improve response to neoadjuvant chemoradiotherapy
EU CTIS ID: 2024-511626-30-00
What this study is testing
The primary objective of this clinical trial is to determine whether 2 weeks metformin treatment activates the tumour immune microenvironment measured by M2 to M1 macrophage polarization, CD8 intratumoral T cell infiltration and increase of the CD8:CD163 ratio when comparing pre- and post-treatment tumour biopsies.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Surgical resectable (
- Adult patients (age ≥ 18 years).
- ECOG performance status 0 or 1 (cf. Appendix A).
- Adequate hematological, renal and hepatic functions defined as: o Absolute Neutrophil Count ≥ 1.5 x 109/L o platelets ≥ 100 x 109/L o haemoglobin ≥ 5.6 mmol o total bilirubin ≤ 1.5 x upper normal limit o creatinine clearance (Cockroft) > 30 ml/min
- Patients must be willing to undergo two endoscopies for investigational purposes.
- Written, voluntary informed consent
You likely can't join if
- Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs.
- 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 func-tion precluding major surgery and/or radiation.
- Serious underlying medical condition which would impair the ability of the patient to re-ceive the planned treatment, including prior allergic reactions to drugs containing Cremo-phor, such as teniposide or cyclosporine.
- Dementia or altered mental status that would prohibit the understanding and giving of in-formed consent
- Patients prescribed metformin or another anti-diabetic drug for any reason.
See the full eligibility criteria
- Surgical resectable (
- Adult patients (age ≥ 18 years).
- ECOG performance status 0 or 1 (cf. Appendix A).
- Adequate hematological, renal and hepatic functions defined as: o Absolute Neutrophil Count ≥ 1.5 x 109/L o platelets ≥ 100 x 109/L o haemoglobin ≥ 5.6 mmol o total bilirubin ≤ 1.5 x upper normal limit o 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
- Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs.
- 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 func-tion precluding major surgery and/or radiation.
- Serious underlying medical condition which would impair the ability of the patient to re-ceive the planned treatment, including prior allergic reactions to drugs containing Cremo-phor, such as teniposide or cyclosporine.
- Dementia or altered mental status that would prohibit the understanding and giving of in-formed consent
- Patients prescribed metformin or another anti-diabetic drug for any reason.
- Patients allergic or intolerant to metformin.
- 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 esophageal 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.