NCT05363007

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 liposomal drugs and immunosuppression. In this study, spleen irradiation (SI) will be added to standard chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 16, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

May 2, 2022

Last Update Submit

October 13, 2023

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancernanoliposomal irinotecanspleen irradiation

Outcome Measures

Primary Outcomes (1)

  • 12W-PFS

    12-week PFS rate (%)

    12 week

Study Arms (2)

Upfront SI

EXPERIMENTAL

Upfront nanoliposomal irinotecan + 5-FU/leucovorin plus SI

Drug: nanoliposomal irinotecanRadiation: spleen irradiation

Add-on SI

EXPERIMENTAL

Add-on SI following limited progression to nanoliposomal irinotecan + 5-FU/leucovorin

Drug: nanoliposomal irinotecanRadiation: spleen irradiation

Interventions

nanoliposomal irinotecanDRUG

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)

Also known as: 5-FU/leucovorin
Add-on SIUpfront SI
spleen irradiationRADIATION

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 SIUpfront SI

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Shih-Hung Yang, MD., PhD.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Hung Yang, MD., PhD.

CONTACT

886-2-23123456b4401064@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

May 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 16, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)