Clinical trial NCT04310553: An Open-label, Multicenter, Prospective Study of Irreversible Electroporation (Nano Knife) Combined With Radiotherapy and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Locally Advanced Pancreatic Caner
Keywords: irreversible electroporation, nano knife, pancreatic cancer.
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2020-03-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: ±7 days
Secondary outcomes:
measure: Time to progress
timeFrame: ±7 days
measure: progress free survival
timeFrame: ±7 days
measure: Observe response rate
timeFrame: ±7 days
measure: disease control rate
timeFrame: ±7 days
measure: clinical benefit rate, CBR
timeFrame: ±7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJiH
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Liwei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: