Calcium Electroporation for the Treatment of Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT03542214
• Recruitment Status: Completed
• First Posted: May 31, 2018
• Last Update Posted: February 25, 2021
• Sponsor: Zealand University Hospital
• Information provided by (Responsible Party): Zealand University Hospital

Study Description

Brief Summary:

In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer Stage IV	Combination Product: Calcium electroporation	Phase 1

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Calcium Electroporation for the Treatment of Colorectal Cancer
• Actual Study Start Date: April 24, 2018
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: January 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Calcium electroporation treatment; Experimental treatment with calcium electroporation for inoperabel colorectal cancer	Combination Product: Calcium electroporation; Patients with inoperable colorectal cancer will be treated with calcium electroporation

Outcome Measures

Primary Outcome Measures :

1. Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used) [ Time Frame: 12 months ]
   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 Outcome Measures :

1. Local response [ Time Frame: 18 months ]
   Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)
2. Systemic respons to calcium electroporation in colorectal cancer. [ Time Frame: 12 months ]
   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
3. Tumorregression [ Time Frame: 12 months ]
   CT/MR scans are performed and analyzed according to RECIST-criteria

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Denmark

Zealand University Hospital

Roskilde, Denmark, 4000

Sponsors and Collaborators

Zealand University Hospital

Investigators

• Principal Investigator: Julie Gehl, DMSc; Zealand University Hospital

More Information

• Responsible Party: Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT03542214
• Other Study ID Numbers: HGH-2017-026
• First Posted: May 31, 2018
• Last Update Posted: February 25, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs