Electrochemotherapy for Non-curable Gastric Cancer

Zealand University Hospital

Status and phase

Unknown

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: Bleomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT04139070

REG-033-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.