Nanoliposomal Irinotecan

DRUG12 trials

Sponsors

University of California, San Francisco, Brown University, Emory University, National Health Research Institutes, Taiwan, PharmaEngine

Conditions

Advanced Biliary Tract CancerBiliary Tract CancerColorectal AdenocarcinomaColorectal CancerGBMGastric AdenocarcinomaGastric CancerGastroesophageal Junction Cancer

Phase 1

Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma

CompletedNCT02022644

University of California, San FranciscoHigh Grade Glioma

Start: 2014-10-23End: 2023-05-31Updated: 2023-06-29

BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma

TerminatedNCT03119064

Brown UniversityGBM, Glioblastoma, Glioblastoma Multiforme

Start: 2017-11-30End: 2021-10-08Updated: 2022-12-13

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

Active, not recruitingNCT03368963

Emory UniversityColorectal Adenocarcinoma, Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma +11

Start: 2018-01-30End: 2025-11-28Target: 64Updated: 2025-01-07

Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors

CompletedNCT03810742

PharmaEngineRefractory Solid Tumors

Start: 2019-03-05End: 2023-10-25Updated: 2023-11-18

Phase I Trial HIPEC With Nal-irinotecan

CompletedNCT04088786

Stony Brook UniversityColorectal Cancer, Gastric Cancer, Mesothelioma +5

Start: 2019-10-22End: 2022-04-14Updated: 2022-05-06

Phase 2

Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy

CompletedNCT03712397

National Health Research Institutes, TaiwanHead & Neck Cancer

Start: 2018-12-24End: 2022-12-31Updated: 2023-04-11

NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

Active, not recruitingNCT04005339

Georgetown UniversityAdvanced Biliary Tract Cancer

Start: 2019-07-29End: 2026-12-31Updated: 2026-01-26

Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

CompletedNCT04752696

Cardiff OncologyPancreatic Ductal Adenocarcinoma

Start: 2021-05-25End: 2024-12-24Updated: 2025-12-22

Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma

National Taiwan University HospitalMetastatic Pancreatic Cancer

Start: 2022-05-01End: 2024-12-31Target: 60Updated: 2023-10-16

A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

RecruitingNCT05472259

Belgian Group of Digestive OncologyMetastatic Pancreatic Ductal Adenocarcinoma

Start: 2022-05-25End: 2027-12-31Target: 134Updated: 2025-02-06

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

RecruitingNCT06219941

AstraZenecaBiliary Tract Cancer, Gastric Cancer, Gastroesophageal Junction Cancer +1

Start: 2023-12-13End: 2027-09-30Target: 224Updated: 2026-02-12

Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors

RecruitingNCT06835387

Tiago Biachi de CastriaSmall Bowel Adenocarcinoma

Start: 2025-06-30End: 2028-08-01Target: 36Updated: 2026-02-17

Related Papers

Phase II study of NALIRIFOX (nanoliposomal irinotecan + oxaliplatin with fluorouracil and folinic acid) in advanced unresectable small bowel tumors.

Journal of Clinical Oncology2026-01-10

Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial.

2025-10-01

CLARITY-PanTumor01: A phase 2 trial of the claudin 18.2-specific antibody-drug conjugate AZD0901 (CMG901) in patients with CLDN18.2-expressing advanced solid tumors.

Journal of Clinical Oncology2024-06-016 citations

OniLon: Phase II trial of trifluridine/tipiracil (TAS-102) and nanoliposomal irinotecan (nal-IRI) in advanced colorectal cancer.

Journal of Clinical Oncology2023-06-012 citations

A Multicenter Phase 1 Trial Evaluating Nanoliposomal Irinotecan for Heated Intraperitoneal Chemotherapy Combined with Cytoreductive Surgery for Patients with Peritoneal Surface Disease.

2022-11-077 citations

Phase 1 study of nanoliposomal irinotecan in combination with trifluridine/tipiracil in refractory solid tumors.

Journal of Clinical Oncology2022-01-19

A phase 2 study of liposomal irinotecan with 5-fluorouracil and leucovorin in squamous cell carcinoma of head and neck or esophagus after prior platinum-based chemotherapy or chemoradiotherapy.

Journal of Clinical Oncology2021-05-204 citations

Nanoliposomal irinotecan and metronomic temozolomide for patients with recurrent glioblastoma: BrUOG329, a phase IB/IIA Brown University Oncology Research Group (BrUOG) trial.

Journal of Clinical Oncology2020-05-201 citations

Phase II study of fluorouracil (FU), leucovorin (LV), and nanoliposomal irinotecan (nal-IRI) in previously treated advanced biliary tract cancer (NAPOLI-2).

Journal of Clinical Oncology2020-02-013 citations

A phase I/II study of trifluridine/tipiracil (TAS-102) in combination with nanoliposomal irinotecan (NAL-IRI) in advanced GI cancers.

Journal of Clinical Oncology2018-05-201 citations

A phase I study of convection-enhanced delivery of nanoliposomal irinotecan using real-time imaging in patients with recurrent high grade glioma.

Journal of Clinical Oncology2015-05-203 citations