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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310553
• Other study ID #: CPOG_006
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2020
• Source: RenJi Hospital
• Contact: Tiebo Mao, MD
• Phone: +86 16621086648
• Email: maotb4[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Caner
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	RenJiH	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	according to RECIST1.1	±7 days
Secondary	Time to progress	according to RECIST1.1	±7 days
Secondary	progress free survival	according to RECIST1.1	±7 days
Secondary	Observe response rate	according to RECIST1.1	±7 days
Secondary	disease control rate	according to RECIST1.1	±7 days
Secondary	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