Electrochemotherapy for Non-curable Gastric Cancer

NCT04139070 | Unknown Phase 1 DMC

• 1 other identifier: REG-033-2019
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Electrochemotherapy; Palliative treatment

Outcome Measures

Primary Outcomes (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).

  3 months

Secondary Outcomes (4)

• Histopathological characterization of tumor biopsies

  3 months

• Gene expression analysis

  3 months

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

  3 months

• Tumor volume

  3 months

Study Arms (1)

Treátment group

EXPERIMENTAL

8 patients are expected to be included in this study. The patients will be treated once with bleomycin in combination with elektroporation

Drug: Bleomycin

Interventions

Bleomycin DRUG

Electroporation in combination with systemically administered bleomycin

Also known as: Electroporation

Treátment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Renal impairment, defined as GFR \<40 ml/min
• Pregnancy
• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Odense University Hospital: collaborator

Study Sites (1)

Department of Surgery, Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Bleomycin; Electroporation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• ismail Gögenur, DMSc

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malene Broholm, MD

CONTACT

41272742; malea@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: June 15, 2020
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

DK (1)