NCT04958044

Brief Summary

In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to tumor necrosis. It is hypothesized that:

  • Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
  • CaEP debulks the tumor, facilitating the patient's ability to eat and drink In this single-arm pilot study, eight patients will be treated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

June 24, 2021

Last Update Submit

October 25, 2022

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety

    Registration of all AE/SAE´s within the first 14 days after treatment. The events will be assessed by CTCAE v4.0.

    14 days after treatment

Secondary Outcomes (4)

  • Dysphagia

    After 7 days, 2-4 weeks and after 6-8 weeks.

  • Pain

    After 7 days, 2-4 weeks and after 6-8 weeks.

  • Qualitiy of life

    After 7 days, 2-4 weeks and after 6-8 weeks.

  • 90 days survival

    90 days

Study Arms (1)

Calcium electroporation

EXPERIMENTAL

Calcium gluconate 0.23 mmol/ml Maxium dosage 20 ml Intra tumoral injection

Drug: Calcium Gluconate

Interventions

Calcium GluconateDRUG

Calcium electroporation

Calcium electroporation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥18 years old.
  • Histological verified malignant tumor in the esophagus.
  • Subjects must have been considered unsuitable for potential curative treatment.
  • Locally progressive disease, and other standard oncological treatment have been administrated and/or considered first.
  • Performance status ECOG/WHO \< 2.
  • Expected survival \> 3 months.
  • Platelets ≥ 50 billion/l, International Normalized Ratio (INR) \< 1,5.
  • Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
  • Women of childbearing potential (WOCBP) and male partners to WOCBP should use adequate contraception during the trial.
  • Subjects must give written informed consent.

You may not qualify if:

  • Coagulation disorder that cannot be corrected.
  • Subjects with a clinically significant cardiac arrhythmia.
  • Pregnancy or lactation.
  • Concurrent treatment with another investigational medicinal product.
  • Stenosis that prevents passage of the endoscope with the device attached.
  • 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 requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Egeland C, Baeksgaard L, Gehl J, Gogenur I, Achiam MP. Palliative Treatment of Esophageal Cancer Using Calcium Electroporation. Cancers (Basel). 2022 Oct 27;14(21):5283. doi: 10.3390/cancers14215283.

    PMID: 36358702DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Calcium Gluconate

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

GluconatesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, Ass. Professor, MD, DMSci, Ph.D., FEBS-OG

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 12, 2021

Study Start

May 25, 2021

Primary Completion

June 13, 2022

Study Completion

June 13, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

DK(1)