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

Not Applicable

• Conditions: Locally Advanced Pancreatic Caner; Pancreatic Cancer
• Interventions: Procedure: Irreversible electroporation

• Registration Number: NCT04310553
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Irreversible electroporation	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	±7 days	according to RECIST1.1

Secondary Outcome Measures

Name	Time	Method
Observe response rate	±7 days	according to RECIST1.1
disease control rate	±7 days	according to RECIST1.1
clinical benefit rate, CBR	±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
Time to progress	±7 days	according to RECIST1.1
progress free survival	±7 days	according to RECIST1.1

Trial Locations

Locations (1)

RenJiH; 🇨🇳 Shanghai, Shanghai, China