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Irinotecan Hydrochloride Liposome Injection (II) in the Treatment of Malignant Tumors of the Biliary Tract: A Collection of Real-World Non-Interventional Clinical Cases

Irinotecan Hydrochloride Liposome Injection (II) in the Treatment of Malignant Tumors of the Biliary Tract: A Collection of Real-World Non-Interventional Clinical Cases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106997
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Interventions

Observation group:None

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically confirmed unresectable or metastatic BTC 2. Aged 18–75 years, regardless of gender 3. ECOG score of 0–2 4. Expected survival time >= 12 weeks 5. At least one measurable lesion (RECIST 1.1 criteria) 6. Received liposomal irinotecan (II) during second-/third-line treatment for BTC 7. Complete records of liposomal irinotecan (II) administration available 8. Fully informed about the study, voluntarily participate, and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Diagnosed with other malignant tumors within the past 5 years 2. Presence of uncontrolled distant metastases, such as brain metastases 3. History of liver transplantation 4. Liver metastases occupying 50% or more of the total liver volume 5. Incomplete case data affecting efficacy and safety evaluation

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Disease control rate;1-year S.R.;

Countries

China

Contacts

Public ContactQian Jun / Cheng Ying

Jiangsu Province Hospital of Chinese Medicine

chengyin82@163.com+86 153 6504 6886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026