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

March 13, 2020 updated by: RenJi Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tiebo Mao, MD
  • Phone Number: +86 16621086648
  • Email: maotb4@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • RenjiH

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 surgery and choose nano knife combined with chemotherapy. Patients who have not previously received first-line chemotherapy will receive systemic chemotherapy for 4-6 cycles of treatment. Imaging evaluation will be performed every 6-8 weeks (± 7 days) during chemotherapy.
Other Names:
  • Nano Knife

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: ±7 days
according to RECIST1.1
±7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to progress
Time Frame: ±7 days
according to RECIST1.1
±7 days
progress free survival
Time Frame: ±7 days
according to RECIST1.1
±7 days
Observe response rate
Time Frame: ±7 days
according to RECIST1.1
±7 days
disease control rate
Time Frame: ±7 days
according to RECIST1.1
±7 days
clinical benefit rate, CBR
Time Frame: ±7 days
EOLTC 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liwei Wang, MD, Renji Hospital

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPOG_006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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