unresectable intractable cancer
Conditions
Interventions
Epirubicin-conjugated polymer micelles (NC-6300) will be administer intravenously within10 minutes before 24 hours of HIFU therapy. The protocol of the 1st and a secondary steppe are NC-6300:80 mg/m2
Sponsors
Tokyo Medical University
Tokyo woman'
s medical university, Institute of advanced biomedical engineering and science, Faculty of advanced techno-surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patients diagnosed as the intractable cancer, pancreatic cancer, biliary tract cancer, osteoncus involved metastatic cancer, and the patients who the US visualization is possible, and the therapy for a so far was not adapted, or effective. Those who understood the purpose and the significance of this work to the sufficiently, and have agreed with the document. 2.The patients whom a subject lesion can evaluate by US and CT (or MRI) 3.The patients who can secure the route of focussing of ultrasonic waves 4.Male and female, the age is more than 20, less than 75 years old 5.The patients by whom principal viscus functionalists (heart, liver, lung, kidney etc) are held 6.Fulfill all the following conditions, all characteristics to be inspected should be carried out within two weeks before the registration neutrophilics more than 1500/mm3, platelet more than 10000/mm30, hgb more than 9.0g/dl, Cr less than 1.5mg/dl, AST less than 120IU/l, ALT less than 120IU/l, T-Bil less than 3mg/dl 7.Performance status of ECOG 0-1 8.The patients who can expect the survive for 12 weeks or more
Exclusion criteria
Exclusion criteria: 1.The patients who has cancer of other organs or is suspected 2.The treatment history of radiotherapy 3.The treatment history of chemotherapy before registration within one month 4.The treatment history of HIFU therapy before registration within two months 5.The patients by whom heomostatic troubles, such as an antiplatelet therapy and an anticoagulation, are expected 6.The patients who has invasion of cancer to stomach and duodenum 7.The patients who has obstructive jaundice (the patients after removing of obstruction is available) 8.The patients by whom tumor adjoins the vena cava inferior and tumor emboli exist in a vena cava inferior (however, good, if the site is avoided) 9.The patients by whom tumor adjoins aorta and a calcified lesion is an exist (however, good, if the site is avoided) to aorta 10.The patients who has cystic lesion in pancreatic cancer 11.The patients of the use history of anthracycline drug 12.The patients who has an anamnestic of a critical drug hypersensitivity 13.The patients who has a radiocontrast-agent allergy 14.The patients who has a critical encephalopathy and pulmonary disease (pneumonitis, pulmonary fibrosis which can be checked on an imaging) 15.The patients who has an anamnestic of congestive heart failure, a symptomatic coronary artery disease, an irregularity of pulse with poor control with medicament, myocardial infarction for less than six months, or unstable angina 16.The patients who has an active infective disease which needs a systemic treatment 17.Pregnant women or the patients who may have become pregnant, and the out-of patient of a contraceptive intention 18.The patients who judged that principal investigator was unsuitable as subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of SDT during SDT and for 1 week and 1 month after SDT | — |
Secondary
| Measure | Time frame |
|---|---|
| the anti-tumor effect and the symptom relief effect for 2 months after SDT | — |
Countries
Japan
Contacts
Public ContactAtsushi Sofuni
Tokyo Medical University gastroenterology and hepatology
Outcome results
None listed