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

NCT ID: NCT06375473

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2027-04-19

Brief Summary

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This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perioperative cohort

Irinotecan liposome II combination therapy regimen for perioperative patients

Irinotecan liposome II combination therapy regimen

Intervention Type DRUG

Irinotecan liposome II combination therapy regimen

First line cohort

Irinotecan liposome II combination therapy regimen for first line advanced patients

No interventions assigned to this group

Second line cohort

Irinotecan liposome II combination therapy regimen for second line advanced patients

No interventions assigned to this group

Late stage third line and above cohort

Irinotecan liposome II combination therapy regimen for third line and above advanced patients

No interventions assigned to this group

Interventions

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Irinotecan liposome II combination therapy regimen

Irinotecan liposome II combination therapy regimen

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taiping Zhang, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital, Beijing, China

Liwei Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, Shanghai, China

Locations

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Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Peking Unicersity First Hospital

Beijing, , China

Site Status RECRUITING

Henan Provincial People's Hospital

Henan, , China

Site Status RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, , China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Renji,Hospital

Shanghai, , China

Site Status RECRUITING

Wuhan Union Hospital of China

Wuhan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Taiping Zhang, doctor

Role: CONTACT

+86 13520132976

Facility Contacts

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He Yifu

Role: primary

18963789042

Taiping Zhang, doctor

Role: primary

+86 13520132976

Zhe Cao, doctor

Role: backup

+86 13693301707

Peng Zhigang

Role: primary

13977167015

Li Ruijun

Role: primary

+86 010-6644 3876

Wu Shikai

Role: primary

+86 15810037307

Zhou Jianwei

Role: primary

+86 010-6644 3876

Hua Yongfei

Role: primary

13095951515

Yu Xianjin

Role: primary

+86 021-64175590

Xu Jin

Role: backup

Wang Liwei, Doctor

Role: primary

+86 13761254228

Wu Bingshui

Role: primary

+86 010-6644 3876

Other Identifiers

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MA-PC-RWS-011

Identifier Type: -

Identifier Source: org_study_id

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