Clinical trial · Interventional
Calcium Electroporation for Early Colorectal Cancer
NCT03694080CI-TRIAL-00039305unknownPhase 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)
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.
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 | 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
- Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.
- interventionNames
- Combination Product: Calcium electroporation
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- 42 days
- description
- Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used
Secondary outcomes (7)
- measure
- Histopathological characterization of the tumor
- timeFrame
- 14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • Patients must be mentally capable of understanding the information given. * Patients must give written informed consent. * Histologically verified adenocarcinoma of the rectum or sigmoid colon. * Tumor described as passable at index endoscopy. * Men or women aged at least 18 years. * Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection. * ASA class I-II (Classification of the American Society of Anesthesiology) Exclusion Criteria: * • Uncorrectable coagulation disorder. * Highly inflamed gastrointestinal tissue which is ulcerated and bleeding * Patients with ICD or pacemaker units. * Ongoing immunosuppressive treatment. * Patients with concomitant use of phenytoin. * Concurrent treatment with an investigational medicinal product. * Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. * Advanced tumor stages, clinical UICC stage IV. * Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery * Acute surgical resection. * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.