Onivyde (nanoliposomal irinotecan)

P=N/A, N=120, Not yet recruiting, Servier (Tianjin) Pharmaceutical Co. LTD.

P2, N=20, Recruiting, Jiangsu Province Hospital; Jiangsu Province Hospital

P2, N=27, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University

P2, N=120, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

P2, N=56, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This study confirmed the potential of combining immunogenic cell death (ICD) inducer irinotecan (IRI) and transforming growth factor-β (TGF-β) inhibitor galunisertib (GAL) to improve tumor immunogenicity and remodel the immunosuppressive TME. Moreover, to ameliorate the in vivo delivery barriers associated with small molecules, neutrophil micropharmacies (NOG) were developed for the codelivery of IRI and GAL, which loaded the commercial liposome formulation of IRI (ONIVYDE, ONI) intracellularly and conjugated the pH-responsive GAL liposome (GLP) on the cell surface. This neutrophil-based formulation resulted in a >4-fold increase in the ratios of the amount of both IRI and GAL accumulated in tumors to the dosage administration, effectively achieving multiple mechanism-mediated sensitization of CRC to ICB therapy.

P2, N=173, Recruiting, Hebei Medical University Fourth Hospital | Not yet recruiting --> Recruiting | N=50 --> 173 | Trial completion date: Dec 2025 --> Mar 2027 | Trial primary completion date: Dec 2024 --> Feb 2026

P=N/A, N=44, Not yet recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University

P2, N=30, Recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University

P2, N=44, Recruiting, Georgetown University | Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> Apr 2025

P2, N=80, Completed, BioLineRx, Ltd. | Phase classification: P2a --> P2

P2, N=60, Recruiting, Hebei Medical University Fourth Hospital | Not yet recruiting --> Recruiting

P2, N=41, Active, not recruiting, Institut de Recherches Internationales Servier | Not yet recruiting --> Active, not recruiting

P1/2, N=36, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2025 --> Jun 2026 | Trial primary completion date: Apr 2025 --> Dec 2025

P2, N=320, Recruiting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Trial completion date: Aug 2024 --> Jul 2026 | Trial primary completion date: Aug 2024 --> Jul 2025

Background: For locally advanced or metastatic gastroenteropancreatic neuroendocrine carcinomas (GEP-NECs), standard chemotherapy typically incorporates etoposide or irinotecan plus platinum agents. Based on current data, the RP2D is 80 mg/m2 of nal-IRI (salt-form) and carboplatin of AUC=4, every 3 weeks. The extension phase II study in GEP-NEC is ongoing.

Multivariate analysis identified the serum CRP, serum CA19-9, duration of first-line GnP therapy, and use (yes/no) of S-1 for second-line treatment as independent predictors for OS. This study concludes that second-line NFF therapy demonstrated a more favorable OS compared to S-1 therapy, however, it is still important to consider the patient background characteristics while selecting the most appropriate treatment.

P1/2, N=76, Completed, XBiotech, Inc. | Active, not recruiting --> Completed | Trial primary completion date: Feb 2024 --> Oct 2023

In our study, we have identified a favorable TiME for L-TTF mPDAC Pts (2nd line CTX) showing CD8 T cell inflamed ("hot") tumor tissues prior to 2nd line CTX. We further present a 9-marker liquid biomarker panel including 9 flow cytometry PBMC population gates for early prediction of 2nd line nal-IRI/5-FU/FA therapy success in mPDAC Pts. With our findings, we aim to advance the personalized treatment of mPDAC Pts e.g. by additionally exploring the potential for immunotherapy in patients with a positive marker signature.

P2, N=122, Recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University

P2, N=31, Not yet recruiting, Peking Union Medical College Hospital; Peking Union Medical College Hospital

P1, N=94, Not yet recruiting, Peking Union Medical College Hospital; Peking Union Medical College Hospital

P2, N=288, Active, not recruiting, Federation Francophone de Cancerologie Digestive | Trial primary completion date: Jun 2024 --> Sep 2024

P1/2, N=52, Enrolling by invitation, National Health Research Institutes, Taiwan | Not yet recruiting --> Enrolling by invitation | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P2, N=106, Active, not recruiting, Federation Francophone de Cancerologie Digestive | Trial primary completion date: Apr 2024 --> Nov 2024

P1, N=177, Active, not recruiting, Ipsen | N=122 --> 177 | Recruiting --> Active, not recruiting

P2, N=87, Recruiting, Fudan University

P2, N=20, Recruiting, The First Affiliated Hospital with Nanjing Medical University

P1/2, N=46, Active, not recruiting, St. Jude Children's Research Hospital | Recruiting --> Active, not recruiting | N=160 --> 46

P2, N=60, Not yet recruiting, TME Pharma AG | Trial completion date: Oct 2027 --> Oct 2028 | Trial primary completion date: Oct 2026 --> Oct 2027

P2, N=31, Active, not recruiting, Peking Union Medical College Hospital

In this study, we have identified a favorable TiME for L-TTF (2nd line CTX) mPDAC patients showing CD8+-T cell inflamed ("hot") tumor tissues prior to 2nd line CTX. We further propose CXCR3+-CD8+ T cells as potential liquid biomarker for predicting 2nd line nal-IRI/5-FU/FA success.

P2, N=36, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P2, N=30, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Patients with UGT1A1*6 or *28 (+/+) should be especially concerned about neutropenia and leukopenia during nal-IRI/FL treatment. Additionally, high AST value and pancreatic head cancer may be risk factors for leukopenia during nal-IRI/FL treatment.

P2, N=120, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University

P=N/A, N=163, Active, not recruiting, Servier Affaires Médicales | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Sep 2024

The addition of durvalumab to a gemcitabine plus cisplatin regimen has significantly improved overall survival in the phase 3 TOPAZ-1 trial and is currently recommended as a standard first-line treatment. The phase 3 ABC-06 and phase 2b NIFTY trials have shown the benefit of second-line fluoropyrimidine plus oxaliplatin, and fluoropyrimidine plus nanoliposomal irinotecan, respectively...However, most patients eventually show resistance to the treatment, and tumor progression occurs within a year. Indeed, there should be further efforts to improve the outcomes of patients with advanced IHCCA.

P2, N=200, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=55, Active, not recruiting, MedSIR | Trial completion date: Mar 2024 --> Jun 2025

P1/2, N=79, Active, not recruiting, Famewave Ltd. | Trial completion date: Mar 2024 --> Jan 2025 | Trial primary completion date: Feb 2024 --> Dec 2024

P2, N=55, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting