NCT06375473

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Apr 2024Apr 2027

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 19, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2027

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

April 16, 2024

Last Update Submit

December 31, 2025

Conditions

Pancreatic Cancer

Keywords

real word study, irinotecan hydrochloride liposome injection II, pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • rwTEAE

    real word treatment emergent adverse event

    3 years

Secondary Outcomes (5)

  • OS

    3 years

  • PFS

    3 years

  • ORR

    3 years

  • TTP

    3 years

  • DCR

    3 years

Study Arms (4)

Perioperative cohort

Irinotecan liposome II combination therapy regimen for perioperative patients

Drug: Irinotecan liposome II combination therapy regimen

First line cohort

Irinotecan liposome II combination therapy regimen for first line advanced patients

Second line cohort

Irinotecan liposome II combination therapy regimen for second line advanced patients

Late stage third line and above cohort

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

Interventions

Irinotecan liposome II combination therapy regimenDRUG

Irinotecan liposome II combination therapy regimen

Perioperative cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic cancer patients in China

You may qualify if:

  • 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.

You may not qualify if:

  • Confirmed pregnant or lactating women;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, 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

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Taiping Zhang, doctor

    Peking Union Medical College Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

  • Liwei Wang, doctor

    Renji Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taiping Zhang, doctor

CONTACT

+86 13520132976tpingzhang@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

April 19, 2024

Primary Completion (Estimated)

April 19, 2027

Study Completion (Estimated)

April 19, 2027

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations

CN(10)