Calcium Electroporation for Early Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Calcium Electroporation for Early Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03694080
• Other study ID #: REG-188-2017
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2019
• Source: Zealand University Hospital
• Contact: Malene Broholm Andersen, MD
• Phone: +45 41272742
• Email: malea[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Combination Product:
• Calcium electroporation
Patients with potentially curable colorectal rectal cancer will be treated preoperatively

Locations

Country	Name	City	State
Denmark	Department of Surgery, Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Histopathological characterization of the tumor	ypTNM staging and tumor regression grade according to current standards	14 days
Secondary	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
Secondary	Immunoscore classification	Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.	14 days
Secondary	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
Secondary	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
Secondary	Metastatic ability after potentially curable surgery	Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.	42 days
Secondary	Cell proliferation as a marker for metastatic ability	Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability	42 days