Irinotecan liposome II combination treatment for pancreatic cancer in China

Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients

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
• Enrollment: 3000 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 10 sites (Hefei, Anhui and 9 other locations)
• Trial ID: NCT06375473 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hefei, Anhui and 9 other locations

• 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)
• 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

Conditions Pancreatic Cancer; real word study, irinotecan hydrochloride liposome injection II, pancreatic cancer