SINAI: Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma
Interventistico
Fase 2
National Taiwan University Hospital
Sponsor: National Taiwan University Hospital
Ultimo Aggiornamento: 16 ottobre 2023 Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.
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.
* 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
* clinically significant co-morbid medical conditions
* prior organ allograft or allogeneic bone marrow transplantation
* received systemic corticosteroids or immunosuppressants within 28 days before registration
* known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
* moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment
* central nervous system metastasis
* prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
* any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury.
* pregnant women or nursing mothers, or positive pregnancy tests
* severe mental disorder
* spleen metastasis or direct invasion
Pensi che questo studio appaia erroneamente?
Dettagli del Disegno
AllocazioneNon-Randomized
Modello di InterventoParallel Assignment
MascheramentoNone (Open Label)
Numero da Arruolare60
Bracci e Interventi
Bracci
Interventi
Tipo: Experimental
Descrizione: Upfront nanoliposomal irinotecan + 5-FU/leucovorin plus SI