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NCT Number: NCT06688240

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)

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: From enrolment until 30 days after last ONIVYDE administration

    (1) Quantify the rate of grade ≥3 neutropenia (primary objective)

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

    Time frame: From enrolment until 30 days after last ONIVYDE administration

    (2) Serious adverse events and serious adverse drug reactions

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

    Time frame: From enrolment until 30 days after last ONIVYDE administration

    (3) Adverse events and adverse drug reactions

Secondary outcomes

  1. 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.

    Time frame: From FPI to 12 months after LPI

    (1) Overall survival

  2. 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.

    Time frame: From FPI to 12 months after LPI

    (2) Overall response

  3. 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.

    Time frame: From FPI to 12 months after LPI

    (3) Progression free survival

  4. 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.

    Time frame: From FPI to 12 months after LPI

    (4) Quality of life assessment(e.g.Karnofsky Performance Status (KPS))

Study contacts

Contact information is provided by the study sponsor or research team.

Qiaohui KANG Sr.PM

CONTACT

[email protected]

86+18500350333

Sponsors and collaborators

Lead sponsor

Servier (Tianjin) Pharmaceutical Co. LTD.

Industry

Collaborators

  • Les Laboratoires Servier

Registry information

Acronym: SEOPAC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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