Electrochemotherapy for Non-curable Gastric Cancer

NCT ID: NCT04139070

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2021-07-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treátment group

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

Group Type: EXPERIMENTAL

Bleomycin

Intervention Type: DRUG

Electroporation in combination with systemically administered bleomycin

Interventions

Bleomycin

Electroporation in combination with systemically administered bleomycin

Intervention Type: DRUG

Other Intervention Names

Electroporation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ismail Gögenur, DMSc

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Department of Surgery, Zealand University Hospital

Køge, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Malene Broholm, MD

Role: CONTACT

malea@regionsjaelland.dk

41272742

Facility Contacts

Malene Broholm, MD

Role: primary

malea@regionsjaelland.dk

+45 41272742

Other Identifiers

REG-033-2019

Identifier Type: -

Identifier Source: org_study_id