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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Locally Advanced Pancreatic Caner
• Intervention / Treatment: Procedure: Irreversible electroporation

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiebo Mao, MD; Phone Number: +86 16621086648; Email: maotb4@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJiH

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / 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 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

Outcome Measure	Measure Description	Time Frame
Overall survival	according to RECIST1.1	±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progress	according to RECIST1.1	±7 days
progress free survival	according to RECIST1.1	±7 days
Observe response rate	according to RECIST1.1	±7 days
disease control rate	according to RECIST1.1	±7 days
clinical benefit rate, CBR	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

• Sponsor: RenJi Hospital
• Collaborators: Ruijin Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Liwei Wang, MD, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: irreversible electroporation, nano knife, pancreatic cancer.
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID 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