Calcium Electroporation for Early Colorectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Combination product: Calcium electroporation

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
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Malene Broholm Andersen, MD; Phone Number: +45 41272742; Email: malea@regionsjaelland.dk
• Study Contact Backup: Name: Ismail Gögenur, DMSc; Email: igo@regionsjaelland.dk

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Recruiting
    • Department of Surgery, Zealand University Hospital
    • Contact: Malene Broholm, MD; Phone Number: +45 41272742; Email: malea@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Calcium Electroporation treatment; Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.	Combination product: Calcium electroporation; Patients with potentially curable colorectal rectal cancer will be treated preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used	42 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (ACTUAL): October 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: REG-188-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No