Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer.
In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.
Patients will be followed for one month after the elective surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Electroporation treatment | Experimental | Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium electroporation | Combination Product | Patients with potentially curable colorectal rectal cancer will be treated preoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological characterization of the tumor | ypTNM staging and tumor regression grade according to current standards | 14 days |
| Immunologic infiltration of the tumor tissue after calcium electroporation |
Not provided
Inclusion Criteria:
• Patients must be mentally capable of understanding the information given.
Exclusion Criteria:
• Uncorrectable coagulation disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malene Broholm Andersen, MD | Contact | +45 41272742 | malea@regionsjaelland.dk | |
| Ismail Gögenur, DMSc | Contact | igo@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ismail Gögenur, DMSc | Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Zealand University Hospital | Recruiting | Køge | 4600 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
| 14 days |
| Immunoscore classification | Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system. | 14 days |
| Systemic immune response according to cytokine analysis | Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed | 42 days |
| Systemic immune response according to flow cytometri | Blood samples will be collected prior to calcium electroporation and again at follow-up. Flow cytometri will be performed to evaluate immunological changes to the treatment. | 42 days |
| Metastatic ability after potentially curable surgery | Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability. | 42 days |
| Cell proliferation as a marker for metastatic ability | Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability | 42 days |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |