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In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.
A total of 6 evaluable patients with inoperable colorectal cancer are expected to be included in the study and the time for inclusion of patients is estimated to be 1-2 years. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.
All patients will be treated once, but in case of residual tumor tissue at follow-up, and if the investigator considers it safe, they will be offered re-treatment. A maximum of 3 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 12 months, starting from first treatment day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium electroporation treatment | Experimental | Experimental treatment with calcium electroporation for inoperabel colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium electroporation | Combination Product | Patients with inoperable colorectal cancer will be treated with calcium electroporation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used) | Safety will be assessed through registration of adverse events related to the treatment. Furthermore, CT scans and follow-up endoscopies are performed as a safety marker to exclude any perforations, bleeding or infections. CTCAE v4 will be used. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local response | Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1) | 18 months |
| Systemic respons to calcium electroporation in colorectal cancer. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Gehl, DMSc | Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Roskilde | 4000 | Denmark |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Blood samples will be collected. Multiplex cytokine analyses and transcriptional analyses will be performed. Furthermore cell adhesion assay will be performed. Additionally circulating tumor DNA will be measured as a marker for the tumor burden
| 12 months |
| Tumorregression | CT/MR scans are performed and analyzed according to RECIST-criteria | 12 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |