Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria

• •Arm A:
• •histologically or cytologically proved PDAC
• •metastatic PDAC
• •failed frontline gemcitabine-based chemotherapy and preparing for application of NHI-reimbursed nal-IRI/FL
• •splenomegaly: SV \> 270 ml (estimated)
• •lymphopenia: \< 1200/mm3
• •no previous radiotherapy, local therapy (eg. radiofrequency ablation, irreversible electroporation, etc.), cell therapy (autologous or allogenic) used for pancreatic cancer
• •presence of at least one measurable lesion outside spleen
• •age between 20 and 75 years at registration
• •ECOG performance status of 0 or 1
• •adequate major organ functions
• •Arm B:
• •limited progressive disease after prior nal-IRI/FL
• •prior treatment of nal-IRI/FL at least 4 doses
• •histologically or cytologically proven PDAC
• •metastatic PDAC before starting prior nal-IRI/FL
• •failed frontline gemcitabine-based chemotherapy before prior nal-IRI/FL
• •presence of at least one measurable lesion outside spleen
• •age between 20 and 75 years at registration
• •ECOG performance status of 0 or 1 or 2 after the chemotherapy phase
• •adequate major organ functions