Locally Advanced Pancreatic Caner, Pancreatic Cancer
Conditions
Keywords
irreversible electroporation, nano knife, pancreatic cancer.
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.
Interventions
PROCEDUREIrreversible 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.
Sponsors
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | ±7 days | according to RECIST1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progress | ±7 days | according to RECIST1.1 |
| progress free survival | ±7 days | according to RECIST1.1 |
| 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 |
Countries
China
Contacts
Primary ContactTiebo Mao, MD
Outcome results
None listed