Advanced Gastric CancerPhase 2NCT04799548
A Phase II Study of TACE Plus PD-1 Antibody in the Locally Advanced Stomach Adenocarcinoma
A Phase 2 study testing Transcatheter Arterial Chemoembolization and Tislelizumab in people with Advanced Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is a phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Transcatheter Arterial Chemoembolization and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 75 years old;
- KPS score >=80;
- Gastric adenocarcinoma diagnosed pathologically;
- According to endoscopic ultrasonography/enhanced CT/MRI/PET-CT examination and laparoscopic exploration, clinical staging is determined to be cT3/4aN+M0 (according to AJCC TNM 8th edition);
- According to the RECIST1.1 standard, there is at least one evaluable lesion in the abdominal CT/MRI;
- The surgeons participating in this study judged the lesion to be resectable;
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- Physical condition allows the surgery;
- The blood routine and biochemical indexes of the subjects met standards within 7 days before enrollment:
- There are no serious concomitant diseases that make the survival time <5 years;
- Female subjects with fertility are not allowed to get pregnant or breastfeeding;
- Be willing and able to comply with the plan and follow-up procedures during the research period.
Who cannot join
- There are any signs of distant metastasis or local unresectable factors;
- Those who are allergic to contrast agents;
- Those who have received cytotoxic chemotherapy, radiotherapy, immunotherapy or radical surgery for the treatment of this gastric cancer, except for corticosteroids;
- Patients who have active autoimmune diseases or have a history of autoimmune diseases but may relapse;
- Any active malignant tumors within 2 years, except the specific cancers under study in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer);
- There is uncontrollable pleural effusion, pericardial effusion or ascites that requires frequent drainage within 14 days before enrollment;
Show all 28Show fewer
- Patients with gastrointestinal bleeding within two weeks prior to enrollment, or those with high bleeding risk as judged by the investigators;
- Gastrointestinal perforation and/or fistula occurred within 6 months before enrollment;
- Upper gastrointestinal obstruction or abnormal physiological function or suffering from malabsorption syndrome, which may affect the absorption of drugs;
- Weight loss >=20% within 2 months before enrollment;
- A history of the following lung diseases: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc.;
- There are uncontrollable systemic diseases including diabetes, hypertension, etc.;
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis, HIV infection, etc.;
- Untreated patients with chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or hepatitis C virus (HCV) RNA positive patients should be excluded;
- Any of the following cardiovascular risk factors (refer to Research Guide)
- Known peripheral nerve disease >=NCI CTCAE Grade 1. However, patients with only the disappearance of the deep tendon reflex (DTR) need not be excluded;
- Moderate or severe renal damage [creatinine clearance equal to or lower than 50 ml/min (calculated according to the Cockroft and Gault equation)], or serum creatinine>ULN;
- People with known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Those who are allergic to any research drug ingredients;
- Have had allogeneic stem cell transplantation or organ transplantation;
- Patients requiring systemic treatment with corticosteroids (dose higher than 10 mg/d of prednisone or equivalent doses of similar drugs) or other immunosuppressive agents <=14 days before enrollment.
- Have received live vaccines within 4 weeks before enrollment. (Remarks: Seasonal flu vaccines are usually inactivated vaccines and are allowed to be used. Vaccines used in the nasal cavity are live vaccines and are not allowed.);
- Have received immunotherapy (such as interleukin, interferon, thymosin, etc.) or any trial treatment within 28 days or 5 half-lives (whichever is shorter, but at least 14 days) before enrollment;
- Palliative radiotherapy was performed within 14 days before enrollment;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2 or any other specific targeting T cell costimulation or checkpoint pathway antibodies or drug therapy;
- Underwent major surgery within 28 days prior to enrollment, unless the surgery was minimally invasive (for example, central venous catheterization via peripheral venipuncture [PICC]);
- For people with a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications;
- There is a potential medical condition or alcohol/drug abuse or dependence that the investigator believes is not conducive to the administration of the study drug or that affects the interpretation of drug toxicity or adverse events.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ZhongShan hospital Fudan university
Shanghai, Shanghai Municipality, 200032
Zhaoqing Tang, MD, PhD, 86-13817125778, tang.zhaoqing@zs-hospital.sh.cn
Xuefei Wang, MD, PhD
About this study
Official title: A Phase II Study of Neoadjuvant Transcatheter Arterial Chemoembolization（TACE）Plus PD-1 Antibody (Tislelizumab) in the Locally Advanced Stomach Adenocarcinoma
This study is a phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACE plus Tislelizumab. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.
Read the detailed description
The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, various clinical trials have shown the benefit of perioperative treatment to gastric cancer patients.
The report of transcatheter arterial chemoembolization (TACE) treatment in gastric cancer is relatively limited, though different case reports have showed its efficacy and safety in advanced gastric cancer. With transarterial infusion chemotherapy, TACE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity. The combination of TACE and PD-1 antibody is expected to further boost tumor immunity.
Meanwhile, Noman et.al. reported hypoxia could upregulate PD-L1 by activating HIF-1alpha. So, embolism may lead to immune evasion of tumors by upregulating PD-L1, but on the other side generate targets for PD-1/PD-L1 therapies.
Based on those knowledges, we designed this phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACE plus Tislelizumab. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and PFS (progression-free survival) of the patients enrolled in this study.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Transcatheter Arterial Chemoembolization, Tislelizumab
- Keywords
- Stomach Cancer, transcatheter arterial chemoembolization, PD-1, PD-L1, neoadjuvant therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial ChemoembolizationDrug
Patients will sequentially receive one cycle TACE (3 weeks), one cycle SOX regimen (3 weeks), one cycle TACE (3 weeks) and one cycle SOX (3 weeks) regimen, a total of 12-week neoadjuvant therapy.
TACE cycle: Day 1: trans-femorally performed with infusion of oxaliplatin (85 mg/m2) into tumor blood vessels. Then, Embosphere® Microspheres (300-500 μm) will be injected for embolism. Day 1-14: Oral Tegafur Gimeracil Oteracil Potassium Capsule 40-60 mg bid.
SOX cycle: Day 1: Oxaliplatin 130mg/m2 intravenous. Day 1-14: Oral Tegafur gimeracil oteracil potassium capsule 40-60 mg bid.
TislelizumabDrug
PD-1 antibody Tislelizumab will be administrated by 200mg, ivgtt, q3w throughout 12-week neoadjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant TACE plus Tislelizumab | Experimental | Not described Receives: Drug: Transcatheter Arterial Chemoembolization; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (pCR) rate
Measured: 1 months
Secondary outcomes (4)
pathologic response rate (pRR)
Measured: 1 months
objective Response Rate (ORR)
Measured: 1 months
overall survival (OS)
Measured: 3 years
progression-free survival (PFS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start30 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuefei Wang, MD, phD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799548
- Sponsor's protocol ID
- ZSGC-TACiE04
- Status last verified
- May 2024
- First submitted
- 31 Jan 2021
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scharping NE, Menk AV, Whetstone RD, Zeng X, Delgoffe GM. Efficacy of PD-1 Blockade Is Potentiated by Metformin-Induced Reduction of Tumor Hypoxia. Cancer Immunol Res. 2017 Jan;5(1):9-16. doi: 10.1158/2326-6066.CIR-16-0103. Epub 2016 Dec 9.
PubMed 27941003Su Z, Shu K, Kang M, Wang G. Pathological complete response from oral chemotherapy combined with trans-arterial chemotherapy and embolization in an unresectable gastric cancer patient: A case report. Medicine (Baltimore). 2019 Jun;98(25):e16075. doi: 10.1097/MD.0000000000016075.
PubMed 31232946Wu ZF, Cao QH, Wu XY, Chen C, Xu Z, Li WS, Yao XQ, Liu FK. Regional Arterial Infusion Chemotherapy improves the Pathological Response rate for advanced gastric cancer with Short-term Neoadjuvant Chemotherapy. Sci Rep. 2015 Dec 1;5:17516. doi: 10.1038/srep17516.
PubMed 26620627Zhang CW, Zou SC, Shi D, Zhao DJ. Clinical significance of preoperative regional intra-arterial infusion chemotherapy for advanced gastric cancer. World J Gastroenterol. 2004 Oct 15;10(20):3070-2. doi: 10.3748/wjg.v10.i20.3070.
PubMed 15378797Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.
PubMed 31378459Xu J, Bai Y, Xu N, Li E, Wang B, Wang J, Li X, Wang X, Yuan X. Tislelizumab Plus Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2020 Sep 1;26(17):4542-4550. doi: 10.1158/1078-0432.CCR-19-3561. Epub 2020 Jun 19.
PubMed 32561664
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Transcatheter Arterial Chemoembolization（TACE）Plus PD-1 Antibody (Tislelizumab) in the Locally Advanced Stomach Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04799548
- Acronym / sponsor ID
- ZSGC-TACiE04
- Conditions
- Advanced Gastric Cancer
- Keywords
- Stomach Cancer, transcatheter arterial chemoembolization, PD-1, PD-L1, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 Mar 2021 (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 a phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACE plus Tislelizumab. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.
Detailed description
The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, various clinical trials have shown the benefit of perioperative treatment to gastric cancer patients.
The report of transcatheter arterial chemoembolization (TACE) treatment in gastric cancer is relatively limited, though different case reports have showed its efficacy and safety in advanced gastric cancer. With transarterial infusion chemotherapy, TACE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity. The combination of TACE and PD-1 antibody is expected to further boost tumor immunity.
Meanwhile, Noman et.al. reported hypoxia could upregulate PD-L1 by activating HIF-1alpha. So, embolism may lead to immune evasion of tumors by upregulating PD-L1, but on the other side generate targets for PD-1/PD-L1 therapies.
Based on those knowledges, we designed this phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACE plus Tislelizumab. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and PFS (progression-free survival) of the patients enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant TACE plus Tislelizumab | Experimental | Drug: Transcatheter Arterial Chemoembolization, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, aged 18 to 75 years old;
- KPS score >=80;
- Gastric adenocarcinoma diagnosed pathologically;
- According to endoscopic ultrasonography/enhanced CT/MRI/PET-CT examination and laparoscopic exploration, clinical staging is determined to be cT3/4aN+M0 (according to AJCC TNM 8th edition);
- According to the RECIST1.1 standard, there is at least one evaluable lesion in the abdominal CT/MRI;
Key exclusion criteria (28 listed)
- There are any signs of distant metastasis or local unresectable factors;
- Those who are allergic to contrast agents;
- Those who have received cytotoxic chemotherapy, radiotherapy, immunotherapy or radical surgery for the treatment of this gastric cancer, except for corticosteroids;
- Patients who have active autoimmune diseases or have a history of autoimmune diseases but may relapse;
- Any active malignant tumors within 2 years, except the specific cancers under study in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer);
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 |
|---|---|---|
| Transcatheter Arterial ChemoembolizationPatients will sequentially receive one cycle TACE (3 weeks), one cycle SOX regimen (3 weeks), one cycle TACE (3 weeks) and one cycle SOX (3 weeks) regimen, a total of 12-week neoadjuvant therapy. TACE cycle: Day 1: trans-femorally performed with infusion of oxaliplatin (85 mg/m2) into tumor blood vessels. Then, Embosphere® Microspheres (300-500 μm) will be injected for embolism. Day 1-14: Oral Tegafur Gimeracil Oteracil Potassium Capsule 40-60 mg bid. SOX cycle: Day 1: Oxaliplatin 130mg/m2 intravenous. Day 1-14: Oral Tegafur gimeracil oteracil potassium capsule 40-60 mg bid. | Drug | neoadjuvant TACE plus Tislelizumab |
| TislelizumabPD-1 antibody Tislelizumab will be administrated by 200mg, ivgtt, q3w throughout 12-week neoadjuvant treatment. | Drug | neoadjuvant TACE plus Tislelizumab |
Primary outcome
pathologic complete response (pCR) rate
Time frame: 1 months
4 secondary outcomes
pathologic response rate (pRR)
Time frame: 1 months
objective Response Rate (ORR)
Time frame: 1 months
overall survival (OS)
Time frame: 3 years
progression-free survival (PFS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 27941003Scharping NE, Menk AV, Whetstone RD, Zeng X, Delgoffe GM. Efficacy of PD-1 Blockade Is Potentiated by Metformin-Induced Reduction of Tumor Hypoxia. Cancer Immunol Res. 2017 Jan;5(1):9-16. doi: 10.1158/2326-6066.CIR-16-0103. Epub 2016 Dec 9.
- Background: PubMed 31232946Su Z, Shu K, Kang M, Wang G. Pathological complete response from oral chemotherapy combined with trans-arterial chemotherapy and embolization in an unresectable gastric cancer patient: A case report. Medicine (Baltimore). 2019 Jun;98(25):e16075. doi: 10.1097/MD.0000000000016075.
- Background: PubMed 26620627Wu ZF, Cao QH, Wu XY, Chen C, Xu Z, Li WS, Yao XQ, Liu FK. Regional Arterial Infusion Chemotherapy improves the Pathological Response rate for advanced gastric cancer with Short-term Neoadjuvant Chemotherapy. Sci Rep. 2015 Dec 1;5:17516. doi: 10.1038/srep17516.
- Background: PubMed 15378797Zhang CW, Zou SC, Shi D, Zhao DJ. Clinical significance of preoperative regional intra-arterial infusion chemotherapy for advanced gastric cancer. World J Gastroenterol. 2004 Oct 15;10(20):3070-2. doi: 10.3748/wjg.v10.i20.3070.
- Background: PubMed 31378459Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.
- Background: PubMed 32561664Xu J, Bai Y, Xu N, Li E, Wang B, Wang J, Li X, Wang X, Yuan X. Tislelizumab Plus Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2020 Sep 1;26(17):4542-4550. doi: 10.1158/1078-0432.CCR-19-3561. Epub 2020 Jun 19.
- 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. This study is not recruiting at the moment.
Xuefei Wang, MD, phD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcatheter Arterial Chemoembolization and Tislelizumab in people with Advanced Gastric Cancer, run by Shanghai Zhongshan 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 11 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoqing Tang, MD, phD (86-13817125778, tang.zhaoqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (pCR) rate (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04799548, which also lists 6 linked publications.
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 23 May 2024.