Pancreatic CancerNCT06578052
Irinotecan Liposome in Combination With Capecitabine
A study testing Irinotecan liposome Capecitabine in people with Pancreatic Cancer, run by Junjie Hang at 1 site in China.
Trial summary
Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells, with high degree of malignancy, insidious onset, difficult early diagnosis, rapid progression, short survival time, and one of the malignant tumors with the worst prognosis, which is known as the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Irinotecan liposome Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients were fully aware of the study, participated voluntarily and signed the informed consent form (ICF);
- aged ≥18 years and ≤80 years;
- patients with histopathologically confirmed unresectable/metastatic pancreatic cancer;
- imaging-confirmed tumor progression after prior treatment with a standard first-line regimen;
- patients with at least one measurable target lesion according to RECIST 1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) physical status score: 0-2;
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- expected survival time ≥ 3 months;
- absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L and hemoglobin ≥ 90 g/L (not transfused with blood, blood products, or corrected with granulocyte colony-stimulating factor or other hematopoietic-stimulating factor in the 14 days prior to the laboratory test);
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value.
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver metastases); total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver metastases); 10. Women of childbearing potential must have had a negative pregnancy test (serum) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after the last administration of the test drug.
- -
Who cannot join
- hypersensitivity to any of the study drugs or their components;
- concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.);
- cardiac function and disease consistent with one of the following conditions
- Long QTc syndrome or QTc interval >480 ms;
- Complete left bundle branch block, degree II or degree III atrioventricular block;
- Severe, uncontrolled arrhythmia requiring pharmacologic therapy;
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- New York Society of Cardiology classification ≥ grade III;
- Cardiac ejection fraction (LVEF) less than 50%;
- History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormality within 6 months prior to recruitment.
- active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies/mL; hepatitis C virus RNA greater than 1x103 copies/mL), except for asymptomatic chronic hepatitis B or hepatitis C carriers;
- human immunodeficiency virus (HIV) infection (HIV-positive);
- imaging confirmation of intestinal obstruction;
- previous or current concurrent other malignancies (except effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment within the past five years);
- pregnant and lactating women and patients of childbearing age who do not wish to use contraception;
- patients with other malignant tumors requiring treatment;
- patients who, in the judgment of the investigator, are not suitable for participation in this study.
- history of pulmonary hemorrhage/coughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose of drug;
- a predisposition to arterial embolism, severe hemorrhage (other than bleeding due to surgery), and severe bleeding within 6 months prior to first dose;
- a combination of symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression
- use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to receiving study drug therapy
- who have used other clinical trial medications within 1 month prior to the first dose;
- pregnant or lactating female patients, subjects of childbearing age who refuse to accept contraception; -
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, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Shenzhen, Guangdong, 518100
Junjie Hang, M.D., +86-13681709736, hjj199141@alumni.sjtu.edu.cn
Junjie Hang, M.D.
About this study
Official title: Irinotecan Liposome in Combination With Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer: Phase II Clinical Study
Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells, with high degree of malignancy, insidious onset, difficult early diagnosis, rapid progression, short survival time, and one of the malignant tumors with the worst prognosis, which is known as the "king of cancers". In recent years, the incidence rate of pancreatic cancer has been increasing both at home and abroad. At present, the palliative treatment of advanced pancreatic cancer is still mainly based on chemotherapy, such as FOLFIRINOX regimen. And after standard first-line treatment, most of the patients have problems such as poor physical status, no standard treatment options and limited options available.
Capecitabine is a selective fluorouracil methionine salt antitumor drug, belongs to the pyrimidine class of antimetabolites, and is the precursor drug of 5-fluorouracil. Its first-line monotherapy for pancreatic cancer is 24% effective, and it is directly recommended by NCCN 2024 V2.0 as a second-line treatment for patients with pancreatic cancer who have failed gemcitabine therapy.The 2024 CSCO Guidelines for Pancreatic Cancer recommend the use of 5-fluorouracil (5-FU)-like regimens as a second-line treatment for patients who have been treated with a gemcitabine-based regimen as first-line treatment. In a clinical study exploring capecitabine in gemcitabine-treated patients with metastatic or unresectable locally advanced pancreatic cancer, 42 patients received oral capecitabine 1,250 mg/m2 twice daily (2,500 mg/m2/d) as intermittent therapy in 3-week cycles consisting of 2 weeks of dosing followed by 1 week of withdrawal. A total of 4 remissions were achieved in 42 evaluable patients, for an overall remission rate of 9.5%.
Read more
Irinotecan Hydrochloride Liposome Injection, the first domestic generic product developed by Shiyao Group, was launched in China in September 2023 with an approved indication for use in combination with 5-FU and calcium folinate (LV) in patients with metastatic pancreatic cancer that has progressed after treatment with gemcitabine. Liposomal irinotecan hydrochloride has been studied in a number of indications including biliary tract cancer, colorectal cancer, glioma, gastric cancer, small cell lung cancer, cervical cancer, breast cancer, head and neck cancer, esophageal cancer, and neuroendocrine cancer. In the bioequivalence trial of Shiyi Group's irinotecan hydrochloride liposome injection, the ORR rate reached 12.9%, the median PFS was 6.24 months, and the median OS was 10.38 months; indicating similar efficacy and a similar safety profile. A randomized, open-label, phase 3 NAPOLI 3 study and the first phase 3 trial comparing two combination chemotherapy regimens in the first-line treatment of patients with pancreatic ductal carcinoma head-to-head was designed to compare the efficacy and safety differences between the NALIRIFOX regimen (irinotecan liposomal, fluorouracil, and calcium folinic acid in combination with oxaliplatin) versus the doublet regimen (gemcitabine + albumin-conjugated paclitaxel) in the first-line treatment of metastatic pancreatic ductal carcinoma efficacy and safety differences in the treatment of metastatic pancreatic ductal cancer. The results showed that the median OS in the NALIRIFOX treatment group was 11.1 months, while the median OS in the dual combination treatment group was 9.2 months (HR=0.83; 95% CI 0.70-0.99; p=0.036).
Based on the above literature research, combined with the efficacy and safety advantages of irinotecan liposome chemotherapy combination regimen in patients with metastatic pancreatic cancer, we propose to carry out a phase II clinical study of irinotecan liposome combined with capecitabine in the second-line treatment of advanced pancreatic cancer. The aim is to explore the efficacy and safety of irinotecan liposomal chemotherapy combined with capecitabine in second-line unresectable or metastatic pancreatic cancer patients, and to explore more effective clinical options for patients with pancreatic cancer that has progressed after previous treatment.
Read the detailed description
This study is a prospective, multicenter, single-arm phase II study. It is expected to include 20 patients with unresectable/metastatic pancreatic cancer who have relapsed after standard treatment, and they will be treated with a regimen of liposomal irinotecan combined with capecitabine. The main research unit is the Shenzhen Hospital of the Chinese Academy of Medical Sciences Cancer Hospital. The study includes a screening period (within 28 days), a treatment period (an estimated 6 cycles, until disease progression or intolerable toxicity occurs), and a follow-up period (12 months for safety follow-up and progression-free survival (PFS) follow-up). Participants sign an informed consent form and undergo baseline examinations during the screening period. Patients who meet the inclusion and exclusion criteria enter the treatment period, and all participants complete the relevant examinations stipulated by the protocol during the treatment process to observe safety, tolerability, and efficacy. The same participant will only receive one dosing plan during the study period. After the end of the treatment period, the follow-up period begins
- Conditions
- Pancreatic Cancer
- Being tested
- Irinotecan liposome Capecitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome CapecitabineDrug
Irinotecan liposome: intravenous infusion, day 1, every 2 weeks Capecitabine: oral, twice daily (bid), days 1 to 7, take for one week and then have a one-week interval.
Each 2-week period is considered a treatment cycle, with an expected treatment of 6 cycles. Subsequent maintenance treatment will be determined by the investigator's protocol until disease progression or intolerable toxicity occurs."
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome Capecitabine | Other | Irinotecan liposome: intravenous infusion, day 1, every 2 weeks (Q2W). Capecitabine: oral, twice daily (bid), days 1 to 7, take for one week and then have a one-week interval.
Each 2-week period is considered a treatment cycle, with an expected treatment of 6 cycles. Subsequent maintenance treatment will be determined by the investigator's protocol until disease progression or intolerable toxicity occurs." Receives: Drug: Irinotecan liposome Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (3)
Objective Response Rate
Objective Response Rate (ORR)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease Control Rate
Disease Control Rate (DCR)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Overall Survival
Overall Survival (OS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start28 Aug 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- "Irinotecan liposome: intravenous infusion, day 1, every 2 weeks (Q2W). Capecitabine: oral, twice daily (bid), days 1 to 7, take for one week and then have a one-week interval. Each 2-week period is considered a treatment cycle, with an expected treatment of 6 cycles. Subsequent maintenance treatment will be determined by the investigator's protocol until disease progression or intolerable toxicity occurs
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junjie Hang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junjie Hang, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578052
- Sponsor's protocol ID
- YW 2024-43
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Liposome in Combination With Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer: Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06578052
- Acronym / sponsor ID
- YW 2024-43
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Junjie HangUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 2024 (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.
Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells, with high degree of malignancy, insidious onset, difficult early diagnosis, rapid progression, short survival time, and one of the malignant tumors with the worst prognosis, which is known as the "king of cancers". In recent years, the incidence rate of pancreatic cancer has been increasing both at home and abroad. At present, the palliative treatment of advanced pancreatic cancer is still mainly based on chemotherapy, such as FOLFIRINOX regimen. And after standard first-line treatment, most of the patients have problems such as poor physical status, no standard treatment options and limited options available.
Capecitabine is a selective fluorouracil methionine salt antitumor drug, belongs to the pyrimidine class of antimetabolites, and is the precursor drug of 5-fluorouracil. Its first-line monotherapy for pancreatic cancer is 24% effective, and it is directly recommended by NCCN 2024 V2.0 as a second-line treatment for patients with pancreatic cancer who have failed gemcitabine therapy.The 2024 CSCO Guidelines for Pancreatic Cancer recommend the use of 5-fluorouracil (5-FU)-like regimens as a second-line treatment for patients who have been treated with a gemcitabine-based regimen as first-line treatment. In a clinical study exploring capecitabine in gemcitabine-treated patients with metastatic or unresectable locally advanced pancreatic cancer, 42 patients received oral capecitabine 1,250 mg/m2 twice daily (2,500 mg/m2/d) as intermittent therapy in 3-week cycles consisting of 2 weeks of dosing followed by 1 week of withdrawal. A total of 4 remissions were achieved in 42 evaluable patients, for an overall remission rate of 9.5%.
Irinotecan Hydrochloride Liposome Injection, the first domestic generic product developed by Shiyao Group, was launched in China in September 2023 with an approved indication for use in combination with 5-FU and calcium folinate (LV) in patients with metastatic pancreatic cancer that has progressed after treatment with gemcitabine. Liposomal irinotecan hydrochloride has been studied in a number of indications including biliary tract cancer, colorectal cancer, glioma, gastric cancer, small cell lung cancer, cervical cancer, breast cancer, head and neck cancer, esophageal cancer, and neuroendocrine cancer. In the bioequivalence trial of Shiyi Group's irinotecan hydrochloride liposome injection, the ORR rate reached 12.9%, the median PFS was 6.24 months, and the median OS was 10.38 months; indicating similar efficacy and a similar safety profile. A randomized, open-label, phase 3 NAPOLI 3 study and the first phase 3 trial comparing two combination chemotherapy regimens in the first-line treatment of patients with pancreatic ductal carcinoma head-to-head was designed to compare the efficacy and safety differences between the NALIRIFOX regimen (irinotecan liposomal, fluorouracil, and calcium folinic acid in combination with oxaliplatin) versus the doublet regimen (gemcitabine + albumin-conjugated paclitaxel) in the first-line treatment of metastatic pancreatic ductal carcinoma efficacy and safety differences in the treatment of metastatic pancreatic ductal cancer. The results showed that the median OS in the NALIRIFOX treatment group was 11.1 months, while the median OS in the dual combination treatment group was 9.2 months (HR=0.83; 95% CI 0.70-0.99; p=0.036).
Based on the above literature research, combined with the efficacy and safety advantages of irinotecan liposome chemotherapy combination regimen in patients with metastatic pancreatic cancer, we propose to carry out a phase II clinical study of irinotecan liposome combined with capecitabine in the second-line treatment of advanced pancreatic cancer. The aim is to explore the efficacy and safety of irinotecan liposomal chemotherapy combined with capecitabine in second-line unresectable or metastatic pancreatic cancer patients, and to explore more effective clinical options for patients with pancreatic cancer that has progressed after previous treatment.
Detailed description
This study is a prospective, multicenter, single-arm phase II study. It is expected to include 20 patients with unresectable/metastatic pancreatic cancer who have relapsed after standard treatment, and they will be treated with a regimen of liposomal irinotecan combined with capecitabine. The main research unit is the Shenzhen Hospital of the Chinese Academy of Medical Sciences Cancer Hospital. The study includes a screening period (within 28 days), a treatment period (an estimated 6 cycles, until disease progression or intolerable toxicity occurs), and a follow-up period (12 months for safety follow-up and progression-free survival (PFS) follow-up). Participants sign an informed consent form and undergo baseline examinations during the screening period. Patients who meet the inclusion and exclusion criteria enter the treatment period, and all participants complete the relevant examinations stipulated by the protocol during the treatment process to observe safety, tolerability, and efficacy. The same participant will only receive one dosing plan during the study period. After the end of the treatment period, the follow-up period begins
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- "Irinotecan liposome: intravenous infusion, day 1, every 2 weeks (Q2W). Capecitabine: oral, twice daily (bid), days 1 to 7, take for one week and then have a one-week interval. Each 2-week period is considered a treatment cycle, with an expected treatment of 6 cycles. Subsequent maintenance treatment will be determined by the investigator's protocol until disease progression or intolerable toxicity occurs
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome Capecitabine | Other | Drug: Irinotecan liposome CapecitabineIrinotecan liposome: intravenous infusion, day 1, every 2 weeks (Q2W). Capecitabine: oral, twice daily (bid), days 1 to 7, take for one week and then have a one-week interval. Each 2-week period is considered a treatment cycle, with an expected treatment of 6 cycles. Subsequent maintenance treatment will be determined by the investigator's protocol until disease progression or intolerable toxicity occurs." |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patients were fully aware of the study, participated voluntarily and signed the informed consent form (ICF);
- aged ≥18 years and ≤80 years;
- patients with histopathologically confirmed unresectable/metastatic pancreatic cancer;
- imaging-confirmed tumor progression after prior treatment with a standard first-line regimen;
- patients with at least one measurable target lesion according to RECIST 1.1 criteria;
Key exclusion criteria (22 listed)
- hypersensitivity to any of the study drugs or their components;
- concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.);
- cardiac function and disease consistent with one of the following conditions
- active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies/mL; hepatitis C virus RNA greater than 1x103 copies/mL), except for asymptomatic chronic hepatitis B or hepatitis C carriers;
- human immunodeficiency virus (HIV) infection (HIV-positive);
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 |
|---|---|---|
| Irinotecan liposome CapecitabineIrinotecan liposome: intravenous infusion, day 1, every 2 weeks Capecitabine: oral, twice daily (bid), days 1 to 7, take for one week and then have a one-week interval. Each 2-week period is considered a treatment cycle, with an expected treatment of 6 cycles. Subsequent maintenance treatment will be determined by the investigator's protocol until disease progression or intolerable toxicity occurs." | Drug | Irinotecan liposome Capecitabine |
Primary outcome
Progression-Free Survival (PFS)
Time frame: TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Progression-Free Survival (PFS)
3 secondary outcomes
Objective Response Rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease Control Rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Overall Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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 14 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irinotecan liposome Capecitabine in people with Pancreatic Cancer, run by Junjie Hang 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 11 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 14 Feb 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 Junjie Hang, M.D. (+86-13681709736, hjj199141@alumni.sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 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 14 Feb 2025.