2024-511626-30-00招募中2 期
MEtformin as a MEtabolic iNTervention in Oesophageal adenocarcinomas to improve response to neoadjuvant chemoradiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Metabolic switch in macrophages measured by M2 to M1 macrophage polarization within the tumour immune microenvironment and the number of CD8 intratumoral T-cell infiltration determined with single cell mRNA sequencing.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Metabolic switch in macrophages measured by M2 to M1 macrophage polarization within the tumour immune microenvironment and the number of CD8 intratumoral T-cell infiltration determined with single cell mRNA sequencing.
Metabolic switch in macrophages measured by M2 to M1 macrophage polarization within the tumour immune microenvironment and the number of CD8 intratumoral T-cell infiltration determined with single cell mRNA sequencing.
次要结局
- Measure changes in T cell infiltration and the CD3:CD163 ratio within the spatial context by multicolor immunohistochemistry (mIHC).
- Detect metabolic changes in macrophages and T cells in the tumour immune microenvi-ronment by SCENITH flow cytometry analysis.
- Pathological response according to pTNM stage and Mandard criteria
- Adverse events based on Common Toxicity Criteria for Adverse Events (CTCAE).
- Progression free survival
- Overall survival
研究者
Coordinating Investigator
Scientific
Amsterdam UMC Stichting
研究点 (2)
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