Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma
NCT ID: NCT05363007
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2022-05-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Upfront SI
Upfront nanoliposomal irinotecan + 5-FU/leucovorin plus SI
nanoliposomal irinotecan
Upfront SI (Arm A): Upfront nanoliposomal irinotecan (80 mg/m2, day 1) + 5-FU/leucovorin (2400 mg/m2, 400 mg/m2) plus SI
Add-on SI (Arm B): Add-on SI following limited progression to prior nanoliposomal irinotecan (last dose used) + 5-FU/leucovorin (last dose used)
spleen irradiation
Upfront SI (Arm A): upfront spleen irradiation (1 Gy/fx, day 1-4) in cycle 2
Add-on SI (Arm B): add-on spleen irradiation (1 Gy/fx, day 1-4) in cycle 1 following limited progression to prior nanoliposomal irinotecan + 5-FU/leucovorin
Add-on SI
Add-on SI following limited progression to nanoliposomal irinotecan + 5-FU/leucovorin
nanoliposomal irinotecan
Upfront SI (Arm A): Upfront nanoliposomal irinotecan (80 mg/m2, day 1) + 5-FU/leucovorin (2400 mg/m2, 400 mg/m2) plus SI
Add-on SI (Arm B): Add-on SI following limited progression to prior nanoliposomal irinotecan (last dose used) + 5-FU/leucovorin (last dose used)
spleen irradiation
Upfront SI (Arm A): upfront spleen irradiation (1 Gy/fx, day 1-4) in cycle 2
Add-on SI (Arm B): add-on spleen irradiation (1 Gy/fx, day 1-4) in cycle 1 following limited progression to prior nanoliposomal irinotecan + 5-FU/leucovorin
Interventions
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nanoliposomal irinotecan
Upfront SI (Arm A): Upfront nanoliposomal irinotecan (80 mg/m2, day 1) + 5-FU/leucovorin (2400 mg/m2, 400 mg/m2) plus SI
Add-on SI (Arm B): Add-on SI following limited progression to prior nanoliposomal irinotecan (last dose used) + 5-FU/leucovorin (last dose used)
spleen irradiation
Upfront SI (Arm A): upfront spleen irradiation (1 Gy/fx, day 1-4) in cycle 2
Add-on SI (Arm B): add-on spleen irradiation (1 Gy/fx, day 1-4) in cycle 1 following limited progression to prior nanoliposomal irinotecan + 5-FU/leucovorin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Shih-Hung Yang, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202110064MIPB
Identifier Type: -
Identifier Source: org_study_id
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