Electrochemotherapy for Non-curable Gastric Cancer

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Collaborator: Odense University Hospital
• Treatments: Bleomycin

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.