Clinical trial · Interventional
Calcium Electroporation for the Treatment of Colorectal Cancer
NCT03542214CI-TRIAL-00050311completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Stage IV | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium electroporation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcium electroporation treatment
- description
- Experimental treatment with calcium electroporation for inoperabel colorectal cancer
- interventionNames
- Combination Product: Calcium electroporation
Primary outcomes (1)
- measure
- Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used)
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (3)
- measure
- Local response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified colorectal tumor * Conferred by multidisciplinary team (radiologists, surgeons and oncologists) discussing options possible for the patient, resulting in agreement that an endoscopic treatment with calcium electroporation should be offered to the patient. * Treatment free interval of minimum 2 weeks. * Thrombocytes ≥ 50 billions/l, INR \>1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K. * Performance status ECOG/WHO ≤2 * Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.) * Trial subject ≥ 18 years. * Trial subject must be able to understand the participants' information. * Signed informed consent. The patients are considered participants in the study after signing of the informed consent. Exclusion criteria: * Coagulative disturbance that cannot be corrected * Pregnancy or lactation (Pregnancy is ruled out in fertile women by an HCG test in a blood sample) * Concurrent participation in other clinical trials that involve experimental drugs or participation in a clinical trial involving experimental drugs within 4 weeks prior to administration of the drug in this study. * Treatment with bevacizumab within the last 4 weeks. * Heavily inflamed colorectal mucus membrane with bleeding or ulcerations. * Implanted colon stent * Other clinical disease or previous treatments that make the investigator deem the patient unfit.
References
Publications (0)
Data not yet available
No reference posted for this study.