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

NCT04310553 | Unknown

• 1 other identifier: CPOG_006
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Locally Advanced Pancreatic Caner

Keywords

irreversible electroporation, nano knife, pancreatic cancer.

Outcome Measures

Primary Outcomes (1)

• Overall survival

  according to RECIST1.1

  ±7 days

Secondary Outcomes (5)

• Time to progress

  ±7 days

• progress free survival

  ±7 days

• Observe response rate

  ±7 days

• disease control rate

  ±7 days

• clinical benefit rate, CBR

  ±7 days

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Irreversible electroporation PROCEDURE

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.

Also known as: Nano Knife

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, no gender limitation;
• Patients with locally advanced pancreatic cancer diagnosed by cell / histopathology, either initially diagnosed or previously treated;
• 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
• ECOG score is 0 \~ 2;
• Expected survival ≥ 3 months;
• 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.
• Full informed consent and signed informed consent.

You may not qualify if:

• 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;
• Patients with severe heart and lung insufficiency or intolerance to general anesthesia;
• Those who are allergic to CT and MRI contrast agents and unable to perform preoperative three-phase dynamic enhanced scanning;
• Ascites due to clinical symptoms, after 2 weeks of conservative medical treatment (excluding drainage of ascites), the ascites still increases gradually;
• Pregnant or lactating women;
• 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;
• Patients that the investigator considers unsuitable for enrollment.

Sponsors & Collaborators

• RenJi Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

RenJiH

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Liwei Wang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiebo Mao, MD

CONTACT

+86 16621086648; maotb4@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: December 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)