Delving into the Latest Updates on Folinic Acid/Fluorouracil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

5-FU/leucovorin, 5-Fluorouracil/Leucovorin, Fluorodex

+ [8]

Target

TYMS

Mechanism

TYMS inhibitors(Thymidylate synthase inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Locally Advanced Pancreatic AdenocarcinomaCentral Nervous System Neoplasms

Inactive Indication-

Originator Organization

University of Wollongong

Active Organization

Jiangsu Provincial People's Hospital

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC4H3FN2O2

InChIKeyGHASVSINZRGABV-UHFFFAOYSA-N

CAS Registry51-21-8

View All Structures (2)

This trial is a prospective, single-arm, single-center, phase II clinical study, mainly targeting subjects with locally advanced pancreatic cancer, to explore the efficacy and safety of adebrelimab combined with irinotecan liposome (II), oxaliplatin, and 5-FU/LV conversion in the treatment of locally advanced pancreatic cancer.

Start Date16 Oct 2024

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

NCT06172036

/ Not yet recruitingPhase 2IIT

A Multicenter, Multi-cohort, Randomized, Phase II Study of Irinotecan Liposome Combined With 5-FU / LV and Oxaliplatin for Resectable Pancreatic Cancer With or Without Addebelizumab

To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate

Start Date20 Jan 2024

Sponsor / Collaborator

Zhejiang University

100 Clinical Results associated with Folinic Acid/Fluorouracil

Login to view more data

100 Translational Medicine associated with Folinic Acid/Fluorouracil

Login to view more data

100 Patents (Medical) associated with Folinic Acid/Fluorouracil

Login to view more data

1

Literatures (Medical) associated with Folinic Acid/Fluorouracil

Oncology

Comparison of the efficacy of nal-IRI+5FU/LV and S-1 in patients with advanced pancreatic cancer refractory to gemcitabine and nab-paclitaxel

Article

Author: Kimura, Yusuke ; Matsuda, Takahisa ; Kikuchi, Yoshinori ; Iwasaki, Susumu ; Takuma, Kensuke ; Yamaguchi, Kazuhisa ; Okano, Naoki

Introduction: Nanoliposomal irinotecan (nal-IRI) + 5- fluorouracil (FU)/leucovorin (LV) is the new standard second-line therapy for advanced pancreatic cancer (PC). Tegafur, gimeracil, and oteracil potassium (S-1) have been used in advanced PC after gemcitabine (GEM) plus nab-paclitaxel treatment, but the clinical difference between nal-IRI+5-FU/LV and S-1 remains unclear. Methods: We retrospectively compared the efficacy and safety of nal-IRI+5-FU/LV and S-1 in patients with advanced PC refractory to GEM plus nab-paclitaxel. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety. Results: We analyzed patients with advanced PC who were refractory to GEM plus nab-paclitaxel from May 2015 to January 2022 at our hospital. Twelve patients treated with nal-IRI+5-FU/LV and 51 patients treated with S-1 were included in this study. Comparing the nal-IRI+5-FU/LV and S-1 groups, the median PFS was 2.95 months vs. 2.10 months (p=0.658), respectively, and the median OS was 8.51 months vs. 5.83 months (p=0.763), respectively. The ORR and DCR were 8.3% and 2.0% (p=0.347) and 58.3% and 49.0% (p=0.750) for the nal-IRI+5-FU/LV and S-1 groups, respectively. There were no significant differences in adverse events between the two groups. In a subgroup analysis, patients under 65 years of age treated with S-1 had a significantly better median OS (HR, 3.46; 95% CI: 1.02-11.71, p=0.046). Conclusion: Nal-IRI+5-FU/LV and S-1 were equally effective and safe as second-line therapy for PC. However, the results suggest that S1 is an option for younger patients, especially those under 65 years.

100 Deals associated with Folinic Acid/Fluorouracil

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	CN	Jiangsu Provincial People's Hospital	16 Oct 2024
Central Nervous System Neoplasms	Phase 1	AU	-	30 Jan 2023

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TOPAZ-1 \| NIFTY \| NALIRICC (ESMO_GI2023)	Phase 2/3	Biliary Tract Neoplasms Second line PD-L1	274	nal-IRI + 5-FU/LV	(liafcqboag) = kshfnpuapz btkmzhpdby (cikvfgrqie ) View more	Positive	01 Jul 2023
				5-FU/LV alone	(liafcqboag) = guyknjfphq btkmzhpdby (cikvfgrqie ) View more
NCT02697058 (NAPOLI-1, ESMO_GI2017)	Phase 3	Metastatic Pancreatic Ductal Adenocarcinoma	-	nal-IRI+5-FU/LV	(ebsdictdft) = ofuzigvabs qjgoefjcpx (nhmdpoluge )	-	28 Jun 2017
				5-FU/LV	(ebsdictdft) = zievdbunys qjgoefjcpx (nhmdpoluge )