Clinical trial · Interventional
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan liposome、5-Fluorouracil、Leucovorin | Drug | — | UNRESOLVED |
| Placebo、5-Fluorouracil、Leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group A
- description
- Irinotecan liposome plus 5-fluorouracil, Leucovorin
- interventionNames
- Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin
- type
- ACTIVE_COMPARATOR
- label
- Treatment group B
- description
- Placebo plus 5-fluorouracil, Leucovorin
- interventionNames
- Drug: Placebo、5-Fluorouracil、Leucovorin
Primary outcomes (1)
- measure
- Overall Survival(OS)
- timeFrame
- The maximum time in follow up was approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed pancreatic cancer; 2. Unresectable locally advanced or metastatic disease ; 3. Documented disease progression after first-line treatment gemcitabine based therapy 4. ECOG: 0-1; 5. Adequate organ and bone marrow function; 6. sign an informed consent. Exclusion Criteria: 1. Active CNS metastasis; 2. Uncontrolled tumor-related pain; 3. Clinically significant GI disorders; 4. Significant cardiovascular disease; 5. Active infection or uncontrolled fever; 6. Pregnant or breast feeding patients; 7. Allergic to a drug ingredient or component; 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
References
Publications (1)
- DERIVEDCui J, Qin S, Zhou Y, Zhang S, Sun X, Zhang M, Cui J, Fang W, Gu K, Li Z, Wang J, Chen X, Yao J, Zhou J, Wang G, Bai Y, Xiao J, Qiu W, Wang B, Xia T, Wang C, Kong L, Yin J, Zhang T, Shen X, Fu D, Gao C, Wang H, Wang Q, Wang L. 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. Signal Transduct Target Ther. 2024 Sep 19;9(1):248. doi: 10.1038/s41392-024-01948-4. PMID 39300077