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Electrochemotherapy for Non-curable Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Bleomycin
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Electrochemotherapy, Palliative treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Surgery, Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treátment group

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Histopathological characterization of tumor biopsies
Endoscopic biopsies will be collected. Standard histology (Characterization of tumor tissue, fibrosis) will be performed and regression grade according to current standards
Gene expression analysis
Specific immunohistochemical staining for PD-1/PD-L1, additionally, samples will be stained for CD3, CD8 and CD28. Finally, gene expression analyses will be performed using the Nano String method. In this current study, we plan to use the PanCancer IO 360 gene expression panel to analyze mRNA. This is a - 770-plex gene expression panel covering the complex interplay between tumor, microenvironment and immune response in cancer, including T and B cell activation and inhibition,, adhesion molecules, chemokines and cytokines, and pattern recognition receptors. This is a predefined gene panel and does not involve extensive mapping of the human genome.
Quality of life with "The European Organization for Research and Treatment of Cancer quality of life questionnaire" (EORTC QLQ-C30)
Quality of Life questionnaires will be collected at baseline and after 8-12 weeks using the EORTC QLQ-C30 questionnaire. The questionnaire consist of 30 questions with a maximum score of 126 points and a minimum score of 30 points.
Tumor volume
Tumor response will be evaluated through endoscopic ultrasound (EUS) to measure tumor volume before and after treatment

Full Information

First Posted
October 23, 2019
Last Updated
August 17, 2020
Sponsor
Zealand University Hospital
Collaborators
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04139070
Brief Title
Electrochemotherapy for Non-curable Gastric Cancer
Official Title
Electrochemotherapy for Non-curable Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Electrochemotherapy, Palliative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treátment group
Arm Type
Experimental
Arm Description
8 patients are expected to be included in this study. The patients will be treated once with bleomycin in combination with elektroporation
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Other Intervention Name(s)
Electroporation
Intervention Description
Electroporation in combination with systemically administered bleomycin
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (CTCAE)
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Histopathological characterization of tumor biopsies
Description
Endoscopic biopsies will be collected. Standard histology (Characterization of tumor tissue, fibrosis) will be performed and regression grade according to current standards
Time Frame
3 months
Title
Gene expression analysis
Description
Specific immunohistochemical staining for PD-1/PD-L1, additionally, samples will be stained for CD3, CD8 and CD28. Finally, gene expression analyses will be performed using the Nano String method. In this current study, we plan to use the PanCancer IO 360 gene expression panel to analyze mRNA. This is a - 770-plex gene expression panel covering the complex interplay between tumor, microenvironment and immune response in cancer, including T and B cell activation and inhibition,, adhesion molecules, chemokines and cytokines, and pattern recognition receptors. This is a predefined gene panel and does not involve extensive mapping of the human genome.
Time Frame
3 months
Title
Quality of life with "The European Organization for Research and Treatment of Cancer quality of life questionnaire" (EORTC QLQ-C30)
Description
Quality of Life questionnaires will be collected at baseline and after 8-12 weeks using the EORTC QLQ-C30 questionnaire. The questionnaire consist of 30 questions with a maximum score of 126 points and a minimum score of 30 points.
Time Frame
3 months
Title
Tumor volume
Description
Tumor response will be evaluated through endoscopic ultrasound (EUS) to measure tumor volume before and after treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malene Broholm, MD
Phone
41272742
Email
malea@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ismail Gögenur, DMSc
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malene Broholm, MD
Phone
+45 41272742
Email
malea@regionsjaelland.dk

12. IPD Sharing Statement

Learn more about this trial

Electrochemotherapy for Non-curable Gastric Cancer

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