Advanced Pancreatic CancerNCT07026123
A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
An observational study of Advanced Pancreatic Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Nal-IRI (Onivyde®)-based treatment and Other second-line treatment
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Jul 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Experimental group: 40 patients Control group: Depends on the real world condition of China Pancreas Data Center (CPDC) project.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Liwei Wang, M.D., 021-58752345, lwwang2013@163.com
About this study
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.
Read the detailed description
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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Nal-IRI (Onivyde®)-based treatment, Other second-line treatment
- Keywords
- Pancreatic Cancer, chemotherapy, liposomal irinotecan, real world research
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nal-IRI (Onivyde®)-based treatmentDrug
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 treatmentDrug
Other second-line treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Liposomal irinotecan (Onivyde®)-based treatment. Receives: Drug: Nal-IRI (Onivyde®)-based treatment | |
| Control group | Real medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project. Receives: Drug: Other second-line treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrollment to death from any cause.
Measured: Up to 24 months
Secondary outcomes (5)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from first-dose to the first documented disease progression or death
Measured: Up to 24 months
Time To Progress (TTP)
Time To Progress (TTP) is defined as the length of time from first-dose until the date of disease progression
Measured: Up to 24 months
Overall Response Rate (ORR)
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
Measured: Up to 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response or stable disease, according to RESIST v1.1
Measured: Up to 24 months
Safety and tolerability by incidence, severity and outcome of adverse events
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
Measured: Until 30 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Servier (Tianjin) Pharmaceutical Co. LTD.
- Responsible party
- Sponsor
- Investigators
- Liwei Wang, M.D., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026123
- Sponsor's protocol ID
- IIT-95013-002-CHN
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
- ClinicalTrials.gov ID
- NCT07026123
- Acronym / sponsor ID
- IIT-95013-002-CHN
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- Pancreatic Cancer, chemotherapy, liposomal irinotecan, real world research
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Servier (Tianjin) Pharmaceutical Co. LTD.
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Drug: Nal-IRI (Onivyde®)-based treatmentLiposomal irinotecan (Onivyde®)-based treatment. |
| Control group | – | Drug: Other second-line treatmentReal medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Experimental group: 40 patients Control group: Depends on the real world condition of China Pancreas Data Center (CPDC) project.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nal-IRI (Onivyde®)-based treatmentNal-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. | Drug | Experimental group |
| Other second-line treatmentOther second-line treatment | Drug | Control group |
Primary outcome
Overall Survival (OS)
Time frame: Up to 24 months
Overall Survival (OS) is defined as the time from enrollment to death from any cause.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Time To Progress (TTP)
Time frame: Up to 24 months
Overall Response Rate (ORR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Safety and tolerability by incidence, severity and outcome of adverse events
Time frame: Until 30 day safety follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liwei Wang, M.D. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Pancreatic Cancer, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liwei Wang, M.D. (021-58752345, lwwang2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.