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NCT03524508
Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer
Phase 2 trial testing Onivyde in Metastatic Biliary Tract Cancer in 178 participants. Completed in 31 December 2021.
30 September 2020
Quick facts
| Lead sponsor | Changhoon Yoo |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 178 |
| Start date | 4 September 2018 |
| Primary completion | 30 September 2020 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
Conditions studied
- Metastatic Biliary Tract Cancer — all drugs for Metastatic Biliary Tract Cancer →
Sponsor
Changhoon Yoo — full company profile →
Who can join
19 and older, any sex, with Metastatic Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of combination of fluorouracil/folinic acid and liposomal irinotecan(Onivyde) compared with fluoruracil/folinic acid in patients with metastatic biliary tract cancer which progressed on 1st line gemcitabine/cisplatin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study.
Yoo C, Kim KP, Jeong JH, Kim I, et al · · 2021 · cited 166× · PMID 34656226 · DOI 10.1016/s1470-2045(21)00486-1 -
PEGylated Lipid Nanoparticle Formulations: Immunological Safety and Efficiency Perspective.
Tenchov R, Sasso JM, Zhou QA. · · 2023 · cited 159× · PMID 37162501 · DOI 10.1021/acs.bioconjchem.3c00174 -
Treatment With Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients With Previously Treated Metastatic Biliary Tract Cancer: The Phase 2b NIFTY Randomized Clinical Trial.
Hyung J, Kim I, Kim KP, Ryoo BY, et al · · 2023 · cited 60× · PMID 36951834 · DOI 10.1001/jamaoncol.2023.0016 -
Cancer Stem Cells: Metabolic Characterization for Targeted Cancer Therapy.
Kaur J, Bhattacharyya S. · · 2021 · cited 21× · PMID 34804950 · DOI 10.3389/fonc.2021.756888 -
Current Standards, Multidisciplinary Approaches, and Future Directions in the Management of Extrahepatic Cholangiocarcinoma.
Wheless M, Agarwal R, Goff L, Lockney N, et al · · 2024 · cited 13× · PMID 38177560 · DOI 10.1007/s11864-023-01153-5 -
Liposomal irinotecan for previously treated patients with biliary tract cancer: A pooled analysis of NIFTY and NALIRICC trials.
Yoo C, Saborowski A, Hyung J, Wenzel P, et al · · 2025 · cited 8× · PMID 40147791 · DOI 10.1016/j.jhep.2025.03.013 -
Nanoliposomal irinotecan in combination with leucovorin and 5-fluorouracil in advanced biliary tract cancers.
Allo G, Can AD, Wahba R, Vogel N, et al · · 2022 · cited 7× · PMID 35070301 · DOI 10.3892/mco.2021.2485 -
First evidence for the antitumor activity of nanoliposomal irinotecan with 5-fluorouracil and folinic acid in metastatic biliary tract cancer.
Taghizadeh H, Unseld M, Schmiderer A, Djanani A, et al · · 2020 · cited 7× · PMID 32556829 · DOI 10.1007/s00280-020-04094-0
Verify or expand the search:
- PubMed search for NCT03524508
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Onivyde
Trials testing the same drug.
- NCT04901702 — Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma · Phase 1, PHASE2 · recruiting
- NCT03719924 — Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma · Phase 2 · completed
- NCT03703063 — Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer · Phase 1 · unknown
- NCT03336216 — A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer · Phase 2 · completed
Other recruiting trials for Metastatic Biliary Tract Cancer
Currently open trials in the same condition.
- NCT07107750 — Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or · Phase 1 · recruiting
- NCT06548412 — CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Bi · Phase 1, PHASE2 · recruiting
Other Changhoon Yoo trials
Trials by the same sponsor.
- NCT05083780 — Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer · Phase 1 · active not recruiting
- NCT03613168 — Trastuzumab in HER2-positive Biliary Tract Cancer · Phase 2 · completed
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 NCT03524508 (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 Changhoon Yoo
- Last refreshed: 24 August 2022
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/NCT03524508.
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