Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma: a Phase II Study (SINAI)
Splenomegaly is common in advanced pancreatic ductal adenocarcinoma (PDAC). The spleen is an important source of immune suppressive cells and phagocytic cells and may mediate the accumulation of liposomal drugs and immunosuppression. In this study, spleen irradiation (SI) will be added to standard chemotherapy.
• 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