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NCT Number: NCT07026123

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

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.

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Key information

Conditions

Advanced Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location contact

Liwei Wang, M.D.

CONTACT

[email protected]

021-58752345

About this study

Chinese patients with pancreatic cancer are mostly treated according to foreign clinical research, lacking the diagnosis and treatment data of efficacy and safety of Chinese population. In the NAPOLI-1 study, irinotecan liposomes (Onivyde®) The combination of 5-fluorouracil and folinic acid (Nal-IRI+5-FU/LV) has shown survival benefits in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have previously received gemcitabine-based treatment. The NAPOLI-3 study showed that NALIRIFOX (Nal-IRI+oxaliplatin+5-FU/LV) significantly improved overall survival (OS) and progression free survival (PFS) compared to albumin bound paclitaxel and gemcitabine in newly diagnosed mPDAC patients. However, the efficacy and safety data of Nal-IRI-based treatment regimens in China are limited. In August 2023, Onivyde® was commercially listed in China. The purpose of this study is to: ① evaluate the real world efficacy and safety of Onivyde®-based treatment schemes in Chinese patients with locally advanced or metastatic pancreatic cancer; ② analyze the efficacy of Onivyde® treatment and the efficacy of all pancreatic cancer patients who have not received relevant treatment using the project data of China Advanced pancreatic cancer Big Data Center (Renji Hospital Cancer Department is the national leading unit), in conjunction with the survival follow-up data of China Center for Disease Control and Prevention of Chronic Non communicable Diseases.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

of the experimental group:

  • Age ≥ 18 years old.
  • Patients with locally advanced or metastatic PDAC diagnosed by pathology.
  • Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU/LV treatment.
  • Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past.
  • The patient voluntarily participates in the study and signs an informed consent form.

Inclusion criteria

of the control group:

  • Age ≥ 18 years old.
  • Patients with locally advanced or metastatic PDAC diagnosed by pathology.
  • Not received Nal IRI (Onivyde®)+ 5-FU/LV treatment in the past.

Exclusion criteria

  • Confirm pregnant or lactating women.
  • The patient's clinical data is not available.
  • The researchers determined that they were not suitable for inclusion in the study due to other circumstances.

Treatment and study plan

Nal-IRI (Onivyde®)-based treatment

Drug

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.

Other second-line treatment

Drug

Other second-line treatment

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 24 months

    Overall Survival (OS) is defined as the time from enrollment to death from any cause.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 24 months

    Progression-Free Survival (PFS) is defined as the time from first-dose to the first documented disease progression or death

  2. Time To Progress (TTP)

    Time frame: Up to 24 months

    Time To Progress (TTP) is defined as the length of time from first-dose until the date of disease progression

  3. Overall Response Rate (ORR)

    Time frame: Up to 24 months

    Overall Response Rate (ORR) is defined as the percentage of people in this study who have a partial response or complete response (according to RESIST v1.1) to the treatment

  4. Disease Control Rate (DCR)

    Time frame: Up to 24 months

    Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response or stable disease, according to RESIST v1.1

  5. Safety and tolerability by incidence, severity and outcome of adverse events

    Time frame: Until 30 day safety follow-up visit

    Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0

Study contacts

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

Jiujie Cui, M.D.

CONTACT

[email protected]

13621958524

Liwei Wang, M.D.

CONTACT

[email protected]

021-58752345

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Servier (Tianjin) Pharmaceutical Co. LTD.

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

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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