Neoadjuvant electrochemotherapy for colorectal cancer - a phase 2 trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Sjaelland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

31 Jan 2025 → ongoing

Decision date (initial)

2025-01-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520755-91-00

EudraCT number

2020-000835-33

ClinicalTrials.gov

NCT04816045

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To investigate if electrochemotherapy is an efficient treatment modality
for tumor down staging compared with electroporation alone prior to
intended curative surgery in patients undergoing treatment for
colorectal cancer.

Secondary objectives 1

1. To investigate if electrochemotherapy will induce immunologic invasion of the primary tumor To investigate if the treatment will induce a systemic immunologic response.

Conditions and MedDRA coding

Colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients must be mentally capable of understanding the information given.
2. Patients must give written informed consent.
3. Endoscopically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
4. Tumor described as passable at index endoscopy.
5. Men or women aged at least 18 years.
6. Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
7. ASA class I-II (Classification of the American Society of Anesthesiology)

Exclusion criteria 15

1. Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
2. Uncorrectable coagulation disorder.
3. Patients with ICD or pacemaker units.
4. Ongoing immunosuppressive treatment.
5. Patients with concomitant use of phenytoin.
6. Myocardial insufficiency, defined as NYHA class >2
7. Concurrent treatment with an investigational medicinal product.
8. 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.
9. Advanced tumor stages, clinical UICC stage IV.
10. Acute surgical resection
11. Pregnancy
12. Medical history of severe pulmonary disease.
13. Previous cumulative dose of bleomycin exceeding 250mg/m2.
14. BMI > 35
15. Renal impairment, defined as eGFR <40 ml/min

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Evaluation of serious adverse events (from study treatment to surgery)
2. Evaluation of any adverse events reported (within 30 days after study treatment)

Secondary endpoints 1

1. Changes in the tumor microenvironment, in terms of infiltrating lymphocytes, bulk and spatial gene and protein expression analysis, and spatial distribution and organization of bacteria in situ

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

Sponsor organisation

Region Sjaelland

Address

Lykkebaekvej 1

City

Koege

Postcode

4600

Country

Denmark

Scientific contact point

Organisation

Region Sjaelland

Contact name

Mikail Gögenur

Public contact point

Organisation

Region Sjaelland

Contact name

Mikail Gögenur

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications