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Clinical Trial Record

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An Open-label, Multicenter, Prospective Study of Irreversible Electroporation (Nano Knife) Combined With Radiotherapy and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer

2017-12-01

2020-12-01

2020-12-01

240

Study Overview

An Open-label, Multicenter, Prospective Study of Irreversible Electroporation (Nano Knife) Combined With Radiotherapy and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer

This is an open-label, multicenter, prospective study of irreversible electroporation (nano knife) combined with radiotherapy and chemotherapy in patients with locally advanced pancreatic cancer.

N/A

  • Pancreatic Cancer
  • Locally Advanced Pancreatic Caner
  • PROCEDURE: Irreversible electroporation
  • CPOG_006

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-03-13  

N/A  

2020-03-13  

2020-03-13  

N/A  

2020-03-17  

2020-03-17  

N/A  

2020-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Arm 1

This project plans to enroll 40 patients receiving nanoknife treatment, our center enrolls 20 patients, and the other two centers will enroll 10 patients each. The number of patients expected to participate in the study is 240.

PROCEDURE: Irreversible electroporation

  • Patients with locally advanced pancreatic cancer diagnosed by cell / histopathology will receive nano knife treatment if the target lesion is not suitable for surgical resection or the target lesion is suitable for surgical resection but patients give up
Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall survivalaccording to RECIST1.1±7 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Time to progressaccording to RECIST1.1±7 days
progress free survivalaccording to RECIST1.1±7 days
Observe response rateaccording to RECIST1.1±7 days
disease control rateaccording to RECIST1.1±7 days
clinical benefit rate, CBREOLTC QLQ-C30 (V3.0 Chinese version) was used to evaluate the quality of life (QOL) according to the European Cancer Research and Treatment Organization (EORTC) core quality of life scale±7 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tiebo Mao, MD

Phone Number: +86 16621086648

Email: maotb4@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age ≥ 18 years, no gender limitation; 2. Patients with locally advanced pancreatic cancer diagnosed by cell / histopathology, either initially diagnosed or previously treated; 3. The target lesion is not suitable for surgical resection, or the target lesion is suitable for surgical resection but the patient gives up the surgical treatment and chooses nano-knife combined with radiotherapy and chemotherapy 4. ECOG score is 0 ~ 2; 5. Expected survival ≥ 3 months; 6. Women of childbearing age must undergo a pregnancy test within 14 days prior to enrollment, and those who have a negative result are eligible for enrollment. Men and women of childbearing age and their sexual partners agreed to use reliable methods of contraception before, during, and at least 90 days after the end of the study. 7. Full informed consent and signed informed consent.
    Exclusion Criteria:
    1. Patients suffering from active infection; high blood pressure (≥160 / 100mmHg) that cannot be controlled by drugs; angina pectoris and unstable angina pectoris that have begun in the last 3 months. Myocardial infarction and cardiac insufficiency occurred within 1 year before enrollment ≥ NYHA Class II), schizophrenia, or history of psychotropic substance abuse; 2. Patients with severe heart and lung insufficiency or intolerance to general anesthesia; 3. Those who are allergic to CT and MRI contrast agents and unable to perform preoperative three-phase dynamic enhanced scanning; 4. Ascites due to clinical symptoms, after 2 weeks of conservative medical treatment (excluding drainage of ascites), the ascites still increases gradually; 5. Pregnant or lactating women; 6. HBV DNA ≥ 104 copies or ≥ 2000 IU / mL, antiviral liver protection treatment is required before HBV-DNA <104 copies (2000 IU / mL) before enrollment, and continue to take antiviral drugs and monitor liver function And hepatitis B virus load; HCV antibody positive or HCV-RNA positive; HIV-infected patients; 7. Patients that the investigator considers unsuitable for enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Ruijin Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • PRINCIPAL_INVESTIGATOR: Liwei Wang, MD, RenJi Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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