Clinical trial · Observational
A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
NCT07026123CI-TRIAL-00091150not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.
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 |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nal-IRI (Onivyde®)-based treatment | Drug | — | UNRESOLVED |
| Other second-line treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental group
- description
- Liposomal irinotecan (Onivyde®)-based treatment.
- interventionNames
- Drug: Nal-IRI (Onivyde®)-based treatment
- label
- Control group
- description
- Real medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project.
- interventionNames
- Drug: Other second-line treatment
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 24 months
- description
- Overall Survival (OS) is defined as the time from enrollment to death from any cause.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria of the experimental group: * Age ≥ 18 years old. * Patients with locally advanced or metastatic PDAC diagnosed by pathology. * Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU/LV treatment. * Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past. * The patient voluntarily participates in the study and signs an informed consent form. Inclusion Criteria of the control group: * Age ≥ 18 years old. * Patients with locally advanced or metastatic PDAC diagnosed by pathology. * Not received Nal IRI (Onivyde®)+ 5-FU/LV treatment in the past. Exclusion Criteria: * Confirm pregnant or lactating women. * The patient's clinical data is not available. * The researchers determined that they were not suitable for inclusion in the study due to other circumstances.
References
Publications (0)
Data not yet available
No reference posted for this study.