Irinotecan liposome II combination treatment for pancreatic cancer in China
Official title: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
Run by Peking Union Medical College Hospital · NCT06375473 · Data updated 2026-11-12
This project will try irinotecan hydrochloride liposome injection II–based combination therapy in adult Chinese patients with pancreatic cancer to see how well it works, how safe it is, and what the costs look like in everyday care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 10 sites (Hefei, Anhui and 9 other locations) |
| Status | Recruiting |
| Started | April 19, 2024 |
| Main results expected | April 19, 2027 |
| Study ends | April 19, 2027 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT06375473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with pathologically or radiographically diagnosed pancreatic ductal adenocarcinoma who are receiving irinotecan hydrochloride liposome injection II–based therapy and can provide informed consent are eligible.
✕Probably not a fit
Pregnant or breastfeeding patients, people not treated with irinotecan liposome II, and patients judged unsuitable by investigators are unlikely to receive benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, observational registry will collect baseline, treatment, and follow-up data from pancreatic cancer patients who receive irinotecan hydrochloride liposome injection II starting May 1, 2024. Participating hospitals will record clinical features, treatment patterns, outcomes, adverse events, and pharmacoeconomic data under informed consent. No experimental interventions are assigned — patients receive treatment per their physicians and data are captured to reflect real-world practice. The analysis aims to describe safety, effectiveness, and resource use of this regimen across diverse Chinese clinical settings.
Why it matters
Potential benefit: If successful, the registry could clarify real-world safety and effectiveness of irinotecan liposome II combinations and guide clinicians on who may benefit and how to use the regimen safely and cost-effectively.
How similar studies have gone: Related liposomal irinotecan products (for example, nal‑IRI) have shown benefit in clinical trials for metastatic pancreatic cancer, but this specific formulation and its real-world use in China are less well documented.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with pancreatic ductal adenocarcinoma diagnosed by pathology or imaging; * Age ≥18 years old, male or female; * Patients receiving treatment based on irinotecan hydrochloride liposome injection II; * The subjects voluntarily joined the study and signed the informed consent. Exclusion Criteria: * Confirmed pregnant or lactating women; * The researchers determined that other conditions were not suitable for inclusion in the study.
Where it's running
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China Recruiting -
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Recruiting -
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China Recruiting -
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Recruiting -
Peking Unicersity First Hospital
Beijing, China Recruiting -
Henan Provincial People's Hospital
Henan, China Recruiting
Show 4 more locations
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Ningbo Medical Center Lihuili Hospital
Ningbo, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting -
Renji,Hospital
Shanghai, China Recruiting -
Wuhan Union Hospital of China
Wuhan, China Recruiting
Study contacts
- Principal investigator: Taiping Zhang, doctor — Peking Union Medical College Hospital, Beijing, China
- Study coordinator: Taiping Zhang, doctor
- Email: tpingzhang@yahoo.com
- Phone: +86 13520132976
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.