NCT05074589

Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer

Completed Phase 3 Last updated 14 August 2023

What this trial tests

Phase 3 trial testing Irinotecan liposome、5-Fluorouracil、Leucovorin in Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy in 298 participants. Completed in 10 March 2022.

Timeline

25 January 2018

Primary endpoint
18 November 2021

10 March 2022

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	298
Start date	25 January 2018
Primary completion	18 November 2021
Estimated completion	10 March 2022
Sites	1 location across China

Drugs / interventions tested

• Irinotecan liposome、5-Fluorouracil、Leucovorin — full drug profile →
• Placebo、5-Fluorouracil、Leucovorin — full drug profile →

Conditions studied

• Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy — all drugs for Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial.
   Cui J, Qin S, Zhou Y, Zhang S, et al · · 2024 · cited 14× · PMID 39300077 · DOI 10.1038/s41392-024-01948-4
2. Preclinical advance in nanoliposome-mediated photothermal therapy in liver cancer.
   Tang L, Yang X, He L, Zhu C, et al · · 2025 · cited 7× · PMID 39891269 · DOI 10.1186/s12944-024-02429-x
3. Theranostic nanoparticles for detection and treatment of pancreatic cancer.
   Agarwal H, Bynum RC, Saleh N, Harris D, et al · · 2024 · cited 6× · PMID 39140128 · DOI 10.1002/wnan.1983
4. Recent Advances and Challenges in the Treatment of Advanced Pancreatic Cancer: An Update on Completed and Ongoing Clinical Trials.
   Shenoy A, Yousif A, Hussain MD. · · 2025 · cited 3× · PMID 40282495 · DOI 10.3390/cancers17081319
5. Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study.
   Ji D, Shen W, Li T, Wang H, et al · · 2024 · cited 1× · PMID 39037543 · DOI 10.1007/s10637-024-01442-2
6. Cost-effectiveness analysis of irinotecan hydrochloride liposome in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma.
   Zhan S, Feng P. · · 2025 · PMID 41311840 · DOI 10.3389/fphar.2025.1596658
7. Importance of landscape exploration and progress in molecular therapies and precision medicine for pancreatic ductal adenocarcinoma.
   Hendi M, Zhang B, Mou YP, Cai XJ. · · 2025 · PMID 40697241 · DOI 10.4251/wjgo.v17.i7.103337