Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clinical Laserthermia Systems AB
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage II-III) or of stage IV disease with hepatic metastasis (staging according to UICC 2009)
Locally advanced disease shall have a lesion diameter less than 4cm
If stage IV disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter
The patient is a candidate for standard chemotherapy (as described at point 5.1)
Age between 18 and 80 years, males and females
Anticipated compliance with treatment and follow-up
Have given informed verbal and written consent to participation in the trial
Have stable and adequate haematologic, renal and hepatic functions:
1. Hemoglobin ≥9 g/dL
2. Platelet count ≥75 x 109/L
3. International normalized ratio (INR) ≤1.7
4. WBC count ≥2 x 109/L
5. Absolute neutrophil count (ANC) ≥1 x 109/L
6. Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN)
7. Serum chemistries sodium, potassium, and calcium within normal limits (WNL)
8. Serum creatinine \<2.0 mg/dL or creatinine clearance \>60 mL/min according to Cockroft-Gault formula
At least a part of the tumour can be treated with imILT without damage to adjacentvital structures
Have an ECOG performance status \<2 (Karnofsky\> 60%)
You may not be if
HIV 1 or 2 positive
Active autoimmune disease which is judged to reduce an anti-tumour immune response
Pregnancy or breast feeding
Have known bleeding disorder that cannot be managed accordingly with the protocol rules, such severe acute or chronic liver failure, other genetic blood diseases not properly managed prior to treatment or other any disease treated with anticoagulant or anti-platelet medication that cannot be interrupted prior to treatment
Clareo Health | Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer
