Status:
UNKNOWN
Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
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 lipos...
Detailed Description
Splenomegaly is common in PDAC. Therefore, we design a phase II study to enroll metastatic PDAC patients who have failed prior gemcitabine-based therapy and have splenomegaly. With add-on SI to standa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- interstitial lung disease
- presence of diarrhea ≥ CTCAE v.5.0 grade 2
- concomitant systemic infection requiring treatment
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05363007
Start Date
May 1 2022
End Date
December 31 2024
Last Update
October 16 2023
Active Locations (2)
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1
National Cheng Kung University Hospital
Tainan, Taiwan
2
National Taiwan University Hospital
Taipei, Taiwan