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Gastric CancerPhase 1NCT04139070

Electrochemotherapy for Non-curable Gastric Cancer

A Phase 1 study testing Bleomycin in people with Gastric Cancer, run by Zealand University Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of electrochemotherapy for non-curable gastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Bleomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteDenmark
Study dates
15 Jun 2020to 1 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be mentally capable of understanding the information given.
  • Patients must give written informed consent.
  • Histologically verified gastric cancer (adenocarcinoma, including Siewert Type II and II)
  • Non-curable disease according to MDT decision
  • Age ≥ 18 years.
  • ASA class I-III (Classification of the American Society of Anesthesiology)
  • Thrombocytes ≥ 50 billions/l, INR >1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K or administration of freshly frozen plasma.
  • Performance status ECOG/WHO ≤2

Who cannot join

  • Locally advanced non-metastatic EGJ/GC patients that may become resectable after pretreatment
  • Inability to perform upper endoscopy with attached equipment.
  • Uncorrectable coagulation disorder
  • Patients with ICD or pacemaker units
  • Myocardial insufficiency, defined as NYHA class >2
  • Concurrent treatment with an investigational medicinal product.
Show all 14Show fewer
  • Renal impairment, defined as GFR <40 ml/min
  • Pregnancy
  • Concurrent inclusion in a medical trial where the intervention may affect safety measures used in the current protocol.
  • 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.
  • Acute pulmonary infection.
  • Medical history of severe pulmonary disease.
  • Previous allergic reactions to bleomycin.
  • Previous cumulative dose of bleomycin exceeding 250mg/m2.

Trial locations and contacts

1 site in 1 country.

Malene Broholm, MD contact

41272742

malea@regionsjaelland.dk

Denmark1 site, 1 recruiting

  • Department of Surgery, Zealand University Hospital

    Køge, 4600

    Malene Broholm, MD, +45 41272742, malea@regionsjaelland.dk

    Recruiting

Other trials in Denmark

About this study

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of electrochemotherapy for non-curable gastric cancer.

Read the detailed description

This is an explorative, phase I clinical trial. Aim of this study is to establish the safety of electrochemotherapy as a palliative treatment for advanced (non-curable) gastric cancer. The study involves recruitment of 8 patients with histologically verified and non-curable gastric cancer (including Siewert Type II and II). Patients will be recruited from Department of Surgery, Odense University Hospital and from Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Electrochemotherapy will take place at Department of Surgery, Zealand University Hospital. After the treatment patients will be referred to Odense University Hospital for follow-up. Electrochemotherapy will be performed as an additive treatment to standard oncological care. Patients are treated once and will be followed with endoscopy, biopsies, scans, blood samples and questionnaires after 4-6 weeks and 8-12 weeks with a minimum interval of 4 weeks.

Conditions
Gastric Cancer
Being tested
Bleomycin
Keywords
Electrochemotherapy, Palliative treatment
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BleomycinDrug

    Also called Electroporation

    Electroporation in combination with systemically administered bleomycin

Study groups in NCT04139070
Study groupRoleWhat they receive
Treátment groupExperimental8 patients are expected to be included in this study. The patients will be treated once with bleomycin in combination with elektroporation
Receives: Drug: Bleomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (CTCAE)

    Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding.

    Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: 3 months

Secondary outcomes (4)

  1. Histopathological characterization of tumor biopsies

    Endoscopic biopsies will be collected. Standard histology (Characterization of tumor tissue, fibrosis) will be performed and regression grade according to current standards

    Measured: 3 months

  2. Gene expression analysis

    Specific immunohistochemical staining for PD-1/PD-L1, additionally, samples will be stained for CD3, CD8 and CD28. Finally, gene expression analyses will be performed using the Nano String method. In this current study, we plan to use the PanCancer IO 360 gene expression panel to analyze mRNA. This is a - 770-plex gene expression panel covering the complex interplay between tumor, microenvironment and immune response in cancer, including T and B cell activation and inhibition,, adhesion molecules, chemokines and cytokines, and pattern recognition receptors. This is a predefined gene panel and does not involve extensive mapping of the human genome.

    Measured: 3 months

  3. Quality of life with "The European Organization for Research and Treatment of Cancer quality of life questionnaire" (EORTC QLQ-C30)

    Quality of Life questionnaires will be collected at baseline and after 8-12 weeks using the EORTC QLQ-C30 questionnaire. The questionnaire consist of 30 questions with a maximum score of 126 points and a minimum score of 30 points.

    Measured: 3 months

  4. Tumor volume

    Tumor response will be evaluated through endoscopic ultrasound (EUS) to measure tumor volume before and after treatment

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2019
  2. Study start15 Jun 2020
  3. Primary completion1 Jan 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04139070
Sponsor's protocol ID
REG-033-2019
Status last verified
Aug 2020
First submitted
23 Oct 2019
Last updated
20 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bleomycin in people with Gastric Cancer, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Malene Broholm, MD (41272742, malea@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (CTCAE) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.

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