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)
NCT ID: NCT06688240
Last Updated: 2024-11-14
Study Results
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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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2024-11-30
2027-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC
this is a prospective, single-arm, multicenter, open-label and non-interventional study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.
* Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
* Documented metastatic disease.
* Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy.
Exclusion Criteria
* Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.
* Pregnant or nursing (lactating) women.
* Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.
* Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.
18 Years
ALL
No
Sponsors
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Les Laboratoires Servier
UNKNOWN
Servier (Tianjin) Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SAF-95013-001-CHN
Identifier Type: -
Identifier Source: org_study_id
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