Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

Colorectal Cancer Clinical Trial

Official title:

Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04816045
• Other study ID #: REG-032-2020
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2021
• Source: Zealand University Hospital
• Contact: Malene Broholm, MD
• Phone: +45 56531500
• Email: malea[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer

Description:

This is a phase 2 randomized controlled trial. The study is blinded. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with electrochemotherapy, compared with electroporation alone, 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 are treated with electrochemotherapy (bleomycin) and 12 patients with electroporation alone (placebo) 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: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• 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.
• Endoscopically suspected or histologically verified malignant tumor 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:

• Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
• Uncorrectable coagulation disorder.
• Patients with ICD or pacemaker units.
• Ongoing immunosuppressive treatment.
• Patients with concomitant use of phenytoin.
• Myocardial insufficiency, defined as NYHA class >2
• 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.
• Acute surgical resection.
• Pregnancy
• Medical history of severe pulmonary disease.
• Previous cumulative dose of bleomycin exceeding 250mg/m2.
• BMI > 35
• Renal impairment, defined as eGFR <40 ml/min

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Electrochemotheraoy
Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin
• Electroporation with saline (placebo)
Electroporation in the control group is performed endoscopically with saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor stage	Preoperative tumor stage will be compared with pathological assessment of the surgical specimen and comared between the two study arms using TNM stage	6 months
Secondary	Gene expressional changes in the tumor microenvironment	Biopises are collected before the intervention and compared with the surgical specimen using NanoString technology. The PanCancer IO 360 gene panel will be used, a predefined panel of 770 genes.	6 months
Secondary	Composition of fusobacterium	To characterize the spatial distribution and organization of bacteria in situ, some of the samples will be assessed microscopically. Confocal laser scanning microscopy will be performed on formalin-fixed, paraffin-embedded tissue of both diseased and normal tissue. This will allow us to investigate treatment affects the bacterial composition of fusobacterium.	6 months
Secondary	PD-1/PD-L1	Immunohistochemical staining for PD-1/PD-L1	6 months
Secondary	CD3	Immunohistochemical staining for CD3	6 months
Secondary	CD8	Immunohistochemical staining for CD8	6 months
Secondary	CD28	Immunohistochemical staining for CD28	6 months
Secondary	VAR2	Immunohistochemical staining for VAR2	6 months