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NCT06688240Not yet recruiting

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)

Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
11 Nov 2024
Start date
Nov 2024
Primary completion date
Jul 2027
Lead sponsor
Servier (Tianjin) Pharmaceutical Co. LTD.
NCT number
NCT06688240

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From Nov 2024 to the primary completion date, Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.
  • Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.

Other

  • Pregnant or nursing (lactating) women.
  • 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.

Who the study is looking for

  • The adult patient (≥18 years of age) has given written informed consent to participate in the study.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.