Calcium Electroporation for Early Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT03694080
• Recruitment Status: Recruiting
• First Posted: October 3, 2018
• Last Update Posted: July 5, 2019
• Sponsor: Zealand University Hospital
• Information provided by (Responsible Party): Zealand University Hospital

Tracking Information

• First Submitted Date: September 25, 2018
• First Posted Date: October 3, 2018
• Last Update Posted Date: July 5, 2019
• Actual Study Start Date: November 1, 2018
• Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2018)

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 42 days ]

Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 1, 2018)

• Histopathological characterization of the tumor [ Time Frame: 14 days ]
  ypTNM staging and tumor regression grade according to current standards
• Immunologic infiltration of the tumor tissue after calcium electroporation [ Time Frame: 14 days ]
  Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
• Immunoscore classification [ Time Frame: 14 days ]
  Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.
• Systemic immune response according to cytokine analysis [ Time Frame: 42 days ]
  Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed
• Systemic immune response according to flow cytometri [ Time Frame: 42 days ]
  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.
• Metastatic ability after potentially curable surgery [ Time Frame: 42 days ]
  Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.
• Cell proliferation as a marker for metastatic ability [ Time Frame: 42 days ]
  Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Calcium Electroporation for Early Colorectal Cancer
• Official Title: Calcium Electroporation for Early Colorectal Cancer
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

Combination Product: Calcium electroporation

Patients with potentially curable colorectal rectal cancer will be treated preoperatively

Study Arms

Experimental: Calcium Electroporation treatment

Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.

Intervention: Combination Product: Calcium electroporation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 1, 2018): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2020
• Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Malene Broholm Andersen, MD; +45 41272742; malea@regionsjaelland.dk

Contact: Ismail Gögenur, DMSc; igo@regionsjaelland.dk

• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT03694080
• Other Study ID Numbers: REG-188-2017
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Zealand University Hospital
• Study Sponsor: Zealand University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ismail Gögenur, DMSc; Zealand University Hospital

• PRS Account: Zealand University Hospital
• Verification Date: July 2019