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

10 days ago

Trial completion date • Trial primary completion date

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

15d

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

15 days ago

New P2 trial • pMMR

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

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

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

1 month ago

New P1/2 trial

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

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

1 month ago

Enrollment closed

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

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

1 month 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)

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

P1, N=0, Withdrawn, SynerGene Therapeutics, Inc. | Not yet recruiting --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 Withdrawn

1 month ago

Trial withdrawal

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

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.

1 month ago

P2 data • Journal

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

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

2ms

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

2 months ago

Trial completion • Trial completion date

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

2ms

Impact of UGT1A1*28 polymorphism in patients with metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX in the NAPOLI 3 trial. (PubMed, Future Oncol)

To evaluate the effect of UGT1A1*28 homozygosity on the safety profile of NALIRIFOX (liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in NAPOLI 3 (NCT04083235). This pre-specified exploratory analysis evaluated safety outcomes by UGT1A1*28 status in patients with mPDAC receiving NALIRIFOX or gemcitabine plus nab-paclitaxel in NAPOLI 3...These findings support the use of full NALIRIFOX dosing irrespective of UGT1A1*28 status. www.clinicaltrials.gov identifier is NCT04083235; EudraCT 2018-003585-14.

2 months ago

Journal

UGT1A1 (UDP glucuronosyltransferase family 1 member A1)

gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)

2ms

Pancreatic metastases are suppressed by photodynamic therapy and irinotecan through macrophage reprogramming in immunodeficient mice. (PubMed, Neoplasia)

Given the lack of pronounced polarization effects with either monotherapy alone, these findings suggest that PDT, when combined with nal-IRI, induces antitumor and antimetastatic responses by remodeling innate immunity, even in the absence of adaptive T-cell activity. It also supports macrophage polarization as a key mechanism underlying PDT-nal-IRI combination therapeutic increase both in local and distant tumor burden.

2 months ago

Preclinical • Journal

GZMB (Granzyme B)

Onivyde (nanoliposomal irinotecan)

2ms

Comparison of Nanoliposomal Irinotecan Plus Fluorouracil/Leucovorin and S-1, Irinotecan, and Oxaliplatin as Second-Line Chemotherapy After Gemcitabine Plus Nab-Paclitaxel for Unresectable Pancreatic Cancer. (PubMed, J Hepatobiliary Pancreat Sci)

S-IROX may be an effective and safe second-line option after GnP, particularly for locally advanced PC.

2 months ago

Journal

CA 19-9 (Cancer antigen 19-9)

gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur) • Onivyde (nanoliposomal irinotecan)