Pancreatic Cancer
Conditions
Brief summary
10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated as primary objective. Secondary objectives will be QoL after imILT, study of the immune reaction after imILT, oncological analysis of patients suffering from LAPC submitted to imILT.
Interventions
Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.
DEVICELaser
Sponsors
Clinical Laserthermia Systems AB
Universita di Verona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage III locally advanced pancreatic cancer * No further neoadjuvant treatments are doable * Eastern Cooperative Oncology Group performance status \< 1
Exclusion criteria
* No other concomitant oncological treatments (hormonal, immunotherapies, etc) * Suffering from other neoplasms * Suffering from HIV * Suffering from autoimmune diseases * Concomitant medication with steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The immunostimulating effects of imILT | Up to 24 months | This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells |
| Overall Survival | Up to 24 months | — |
| Progression free survival (PFS) | Up to 24 months | — |
| Disease specific survival (DSS) | Up to 24 months | — |
Countries
Italy
Outcome results
None listed