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A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)

NCT06688240 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-11-14

No results posted yet for this study

Summary

The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.

Primary objective

To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:

1. Quantify the rate of grade ≥3 neutropenia (primary objective)
2. Serious adverse events and serious adverse drug reactions
3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.

(1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment

Conditions

Sponsors & Collaborators

  • Les Laboratoires Servier

    collaborator UNKNOWN

  • Servier (Tianjin) Pharmaceutical Co. LTD.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2027-07-31
Completion
2027-07-31

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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 NCT06688240 on ClinicalTrials.gov