Calcium Electroporation for Early Colorectal Cancer

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

May 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Calcium Electroporation for Early Colorectal Cancer

Official Title ^ICMJE

Calcium Electroporation for Early Colorectal Cancer

Brief Summary

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2019

Estimated Primary Completion Date

May 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

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

，

Study Sponsor ^ICMJE

Zealand University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Ismail Gögenur, DMSc Zealand University Hospital

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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