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NCT05363007: SINAI
Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma
Phase 2 trial testing nanoliposomal irinotecan in Metastatic Pancreatic Cancer in 60 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 May 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 2 locations across Taiwan |
Drugs / interventions tested
- nanoliposomal irinotecan — full drug profile →
- spleen irradiation
Conditions studied
- Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →
Sponsor
National Taiwan University Hospital
Who can join
Adults 20 to 75, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeted spleen modulation: a novel strategy for next-generation disease immunotherapy.
Dong W, Li Y, Fei Q, Li S, et al · · 2025 · cited 16× · PMID 40225564 · DOI 10.7150/thno.111116
Verify or expand the search:
- PubMed search for NCT05363007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of nanoliposomal irinotecan
Trials testing the same drug.
- NCT04088786 — Phase I Trial HIPEC With Nal-irinotecan · Phase 1 · completed
- NCT03712397 — Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy · Phase 2 · completed
- NCT02022644 — Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma · Phase 1 · completed
Other recruiting trials for Metastatic Pancreatic Cancer
Currently open trials in the same condition.
- NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
- NCT06861088 — The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer · Phase 3 · recruiting
- NCT06843551 — The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation · Phase 2 · recruiting
- NCT06951997 — QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer · Phase 2 · recruiting
- NCT06533332 — A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors · Phase 1 · recruiting
Other National Taiwan University Hospital trials
Trials by the same sponsor.
- NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
- NCT05396222 — A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar · NA · not yet recruiting
- NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
- NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
- NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05363007 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 16 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05363007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing