A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China

NCT07026123 | Not Yet Recruiting

• 1 other identifier: IIT-95013-002-CHN
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.

Conditions

Advanced Pancreatic Cancer

Keywords

Pancreatic Cancer; chemotherapy; liposomal irinotecan; real world research

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall Survival (OS) is defined as the time from enrollment to death from any cause.

  Up to 24 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to 24 months

• Time To Progress (TTP)

  Up to 24 months

• Overall Response Rate (ORR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

• Safety and tolerability by incidence, severity and outcome of adverse events

  Until 30 day safety follow-up visit

Study Arms (2)

Experimental group

Liposomal irinotecan (Onivyde®)-based treatment.

Drug: Nal-IRI (Onivyde®)-based treatment

Control group

Real medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project.

Drug: Other second-line treatment

Interventions

Nal-IRI (Onivyde®)-based treatment DRUG

Nal-IRI (Onivyde®) combined with 5-FU/LV is used for metastatic pancreatic ductal adenocarcinoma patients who have progressed after treatment with gemcitabine. The recommended dose of Nal-IRI (Onivyde®) is 70 mg/m\^2, administered intravenously for 90 minutes, once every 2 weeks. In patients known to be homozygous for the UGT1A1 \* 28 allele, the recommended starting dose of Nal-IRI (Onivyde®) is 50 mg/m\^2, administered intravenously within 90 minutes. Based on tolerance, increase the dose of Nal-IRI (Onivyde®) to 70 mg/m\^2 in subsequent cycles.

Experimental group

Other second-line treatment DRUG

Other second-line treatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experimental group: 40 patients Control group: Depends on the real world condition of China Pancreas Data Center (CPDC) project.

You may qualify if:

• Age ≥ 18 years old.
• Patients with locally advanced or metastatic PDAC diagnosed by pathology.
• Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU/LV treatment.
• Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past.
• The patient voluntarily participates in the study and signs an informed consent form.
• Age ≥ 18 years old.
• Patients with locally advanced or metastatic PDAC diagnosed by pathology.
• Not received Nal IRI (Onivyde®)+ 5-FU/LV treatment in the past.

You may not qualify if:

• Confirm pregnant or lactating women.
• The patient's clinical data is not available.

Sponsors & Collaborators

• RenJi Hospital: lead
• Servier (Tianjin) Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Liwei Wang, M.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liwei Wang, M.D.

CONTACT

021-58752345; lwwang2013@163.com

Jiujie Cui, M.D.

CONTACT

13621958524; cuijiujie@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)