Trial · NCT06687876
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | activation of the tumour immune microenvironment after two week metformin treatment. | at enrollment and at end of metformin treatment at 2 weeks. | Activation of the tumor immune microenvironment measured by M2 to M1 polarization, CD8 intratumoral T cell infiltration and an increase of CD3 to CD163 ratio when comparing tumor biopsies from before and after treatment. |
| Secondary | Tolerability and toxicity of metformin | From starting treatment to end of treatment at 7 weeks. | Adverse events based on Common Toxicity Criteria for Adverse Events |
| Secondary | Metabolic change of cancer cells with SCENITH analysis. | at enrollment and at end of metformin treatment at 2 weeks | To determine whether SCENITH can be used to assay the change in metabolic state. |
| Secondary | Pathological response | After surgery, approximately 16 weeks after enrollment. | According to the Mandard criteria. |
| Secondary | Progression-free survival (PFS). | 60 months | Assess the PFS of patients within the study |
| Secondary | Overall survival (OS) | 60 months | Determine overall survival of patients within the study |
| Other | Can metformin induce a metabolic switch in macrophages, T cells and cancer cells. | 20 months | Using single cell RNA sequencing or SCENITH analysis. |
| Other | Change in subgroups in peripheral blood mononuclear cells (PMBCs) after metformin treatment. | 20 months | Are the changes to the tumour immune microenvironment also detected in subgroups of peripheral blood mononuclear cells (PBMCs) taken at the same time points. |
| Other | Establish immune cell co-cultures with primary tumour cells and investigate the cell interactions and anti-tumour responses in presence of metformin. | 20 months | Establish autologous immune cell co-cultures with primary tumor cells to investigate immune cell-tumor cell interactions and anti-tumour responses in the presence of metformin. |
| Other | Cytokine release profile measured in serum before and after metformin treatment. | 20 months | Determine changes in cytokine expression in serum before and after metformin treatment. |
| Other | changes in ctDNA in patient plasma before and after metformin treatment. | 20 months | To evaluate changes in the presence of circulating tumour DNA (ctDNA) extracted from patient plasma and their correlation with pathological response and survival. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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