Neoadjuvant NALIRIFOX is a safe and active regimen in R/BR PDAC with a low post-operative complication rate, high treatment completion and R0 resection rates, and meaningful clinical responses. These findings support further investigation of NALIRIFOX as part of a total neoadjuvant therapy (TNT) approach in PDAC. [ClinicalTrials.gov identifier: NCT03483038].

1 month ago

Journal

CA 19-9 (Cancer antigen 19-9)

5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)

2ms

GIANT: Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (clinicaltrials.gov)

P2, N=176, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial primary completion date: Jun 2026 --> Mar 2026

2 months ago

Trial primary completion date

UGT1A1 (UDP glucuronosyltransferase family 1 member A1)

gemcitabine • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical

2ms

NCI-2019-07966: Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma (clinicaltrials.gov)

P2, N=52, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2027 --> May 2028 | Trial primary completion date: Dec 2026 --> Dec 2027

2 months ago

Trial completion date • Trial primary completion date

HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)

Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • 5-fluorouracil • Onivyde (nanoliposomal irinotecan)

2ms

3082-CL-0301: A study to confirm the safety of ASP3082, and if it delays tumor growth in people with pancreatic cancer, when given with either mFOLFIRINOX or NALIRIFOX chemotherapies (2025-523684-38-00)

P2/3, N=35, Not yet recruiting, Astellas Pharma Global Development Inc.

2 months ago

New P2/3 trial

KRAS (KRAS proto-oncogene GTPase)

KRAS mutation • KRAS G12D • KRAS G12

5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan)

2ms

A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov)

P2, N=60, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027

2 months ago

Trial completion date • Trial primary completion date

5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)

2ms

Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial (clinicaltrials.gov)

P2, N=84, Not yet recruiting, Sun Yat-sen University

2 months ago

New P2 trial • pMMR

5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • AiRuiLi (adebrelimab)

3ms

NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer (clinicaltrials.gov)

P1/2, N=55, Recruiting, West China Hospital

3 months ago

New P1/2 trial

5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • AiRuiLi (adebrelimab)

3ms

RAD-NALIRIFOX: Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer (clinicaltrials.gov)

P2, N=42, Active, not recruiting, Shandong Cancer Hospital and Institute | Not yet recruiting --> Active, not recruiting

3 months ago

Enrollment closed

5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)

3ms

ONITT: Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma (clinicaltrials.gov)

P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Trial primary completion date: Dec 2025 --> Dec 2026

3 months ago

Trial primary completion date

EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)

temozolomide • Talzenna (talazoparib) • Onivyde (nanoliposomal irinotecan)

3ms

SGT-53 in Children With Recurrent or Progressive CNS Malignancies (clinicaltrials.gov)

P1, N=0, Withdrawn, SynerGene Therapeutics, Inc. | Not yet recruiting --> Withdrawn

3 months ago

Trial withdrawal

Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53

3ms

Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: updated analysis of survival and circulating and genetic biomarkers from the phase II nITRO trial. (PubMed, ESMO Open)

Long-term results from the nITRO trial confirm the activity of perioperative NALIRIFOX in resectable PDAC. Inflammatory, genomic, and pharmacogenomic biomarkers strongly influenced treatment response, surgical eligibility, survival, and toxicity. Biomarker integration could enable more precise patient stratification and guide personalized perioperative strategies in PDAC.

3 months ago

P2 data • Journal

TNFA (Tumor Necrosis Factor-Alpha) • DPYD (Dihydropyrimidine Dehydrogenase)

5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)

3ms

Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas (clinicaltrials.gov)

P2, N=41, Completed, Institut de Recherches Internationales Servier | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Sep 2025

3 months ago

Trial completion • Trial completion date

5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium