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

NCT07026123 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-06-18

No results posted yet for this study

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

Interventions

DRUG

Nal-IRI (Onivyde®)-based treatment

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.

DRUG

Other second-line treatment

Other second-line treatment

Sponsors & Collaborators

  • Servier (Tianjin) Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Liwei Wang, M.D. · Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026123 on ClinicalTrials.gov