A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Histologically and/or cytologically proven NCCN locally advanced PC
Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.
DaRT indication validated by a multidisciplinary team.
Measurable lesion per RECIST (version 1.1) criteria
Concomitant chemotherapy or immunotherapy within the past 4 weeks
Prior radiation therapy to the pancreas
CA 19-9 > 1000 Units/ml
Fit for surgical exploration unless the patient refuses surgery
Single group
DaRT seeds insertion
DeviceAn intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Feasibility- DaRT seed placement
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer
Local control evaluation according to RECIST v1.1
To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels
Change in CA 19-9 levels
Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds
Tumor Coverage
Efficacy- Alpha DaRT seeds
Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Exploratory Objective -to evaluate the changes in the immune markers by Blood samples for immune response
Changes in immune markers following treatment ,These biomarkers include: * CD3 * CD4 * CD8 * CD69 * CD137
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