Status:
UNKNOWN
Electrochemotherapy for Non-curable Gastric Cancer
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Odense University Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 invol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04139070
Start Date
June 15 2020
End Date
July 1 2021
Last Update
August 20 2020
Active Locations (1)
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1
Department of Surgery, Zealand University Hospital
Køge, Denmark, 4600