Colorectal Liver Metastases (CRCLM)RAPID-uCRLMNCT07919951
RAPID for Unresectable Colorectal Liver Metastases
A study testing RAPID Procedure in people with Colorectal Liver Metastases (CRCLM) and Colorectal Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the RAPID procedure works to treat colorectal cancer that has spread to the liver and cannot be removed by surgery. It will also learn about the safety of the procedure. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
- What is being tested?
- RAPID Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2026to 1 Dec 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years; ECOG performance status 0 to 1.
- Histologically confirmed colorectal adenocarcinoma; primary tumor radically resected, or resectable synchronously or in a staged manner.
- Unresectable colorectal liver metastases as assessed by a multidisciplinary team (hepatobiliary surgery, medical oncology, radiology).
- No unresectable extrahepatic metastases.
- Received standard chemotherapy plus targeted therapy, with stable disease.
- BRAF V600E wild-type and microsatellite stable (MSS).
- Child-Pugh class A, without clinically significant portal hypertension.
- Signed written informed consent and able to comply with the protocol and follow-up.
Who cannot join
- Unresectable extrahepatic metastases (resectable pulmonary nodules are permitted).
- Primary colorectal tumor not amenable to radical resection.
- BRAF V600E mutation or microsatellite instability-high (MSI-H).
- Severe hepatic insufficiency (Child-Pugh class B or C), or clinically significant portal hypertension.
- Severe cardiopulmonary or renal insufficiency, or judged by the surgeon to be unable to tolerate two-stage major surgery.
- Other malignancy diagnosed within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Prior solid organ transplantation; HIV infection.
- Pregnant or breastfeeding women, or women planning pregnancy during the study
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
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
13622860325, pangli5@mail.sysu.edu.cn
Chao Liu, PhD, MD
About this study
Official title: Efficacy of the RAPID Procedure (Resection and Partial Liver Transplantation With Delayed Total Hepatectomy) for Unresectable Colorectal Liver Metastases: A Prospective Clinical Study
The goal of this clinical trial is to learn if the RAPID procedure works to treat colorectal cancer that has spread to the liver and cannot be removed by surgery. It will also learn about the safety of the procedure. The main questions it aims to answer are:
- How many participants are alive without the cancer progressing or returning 2 years after the first-stage surgery?
- How many participants complete the second-stage surgery, and how quickly does the liver graft grow between the two stages?
- What medical problems do participants have around the time of surgery, including serious complications?
Read more
Participants will:
- Undergo the first-stage surgery: removal of the left part of the liver and implantation of a small liver graft, with the right portal vein tied off to help the graft grow;
- Have blood tests and ultrasound checks after surgery, and regular CT or MRI scans to measure graft growth; (4) Undergo the second-stage surgery to remove the remaining diseased liver once the graft has grown enough (5) Visit the clinic every 3 months for up to 2 years after the second-stage surgery for checkups, imaging, and blood tests to see if the cancer has returned
Read the detailed description
This is a prospective clinical trial evaluating the RAPID procedure (Resection and Partial Liver Transplantation with Delayed Total Hepatectomy) in patients with unresectable colorectal liver metastases (uCRLM).
Stage 1 is performed on Day 0: partial hepatectomy is carried out to remove the tumor-bearing portion of the liver, preserving the remaining native liver as temporary metabolic support. A small-for-size graft is implanted orthotopically. The portal vein supplying the preserved native liver is ligated to redirect portal flow to the graft, while the hepatic artery supplying the preserved native liver is preserved.
Interstage monitoring begins on postoperative Day 1. Liver function (TBIL, INR, ALT, AST) and graft blood flow (Doppler ultrasound) are assessed. Graft volume is measured by CT/MRI volumetry on postoperative Days 7 and 14, and every 7 days thereafter. The criteria for proceeding to Stage 2 (all must be met) are: graft GRWR ≥0.8%, and multidisciplinary team (MDT) confirmation that Stage 2 surgery can proceed. The first formal assessment is on postoperative Day 7.
Stage 2 is performed once the criteria are met: the remnant native liver is removed, and the graft is preserved.
Postoperative follow-up continues for up to 2 years after Stage 2 (with exploratory extension to 5 years), with visits every 3 months. Assessments include history and physical examination, ECOG status, liver function, CEA/CA19-9, contrast-enhanced CT of the chest and abdomen. Tumor progression or recurrence is adjudicated by an independent imaging reviewer. The primary endpoint is the 2-year tumor event-free survival rate, defined as the time from Stage 1 surgery to tumor progression, recurrence, or death from any cause, whichever occurs first.
This response is AI-generated, for reference only.
- Being tested
- RAPID Procedure
- Keywords
- RAPID procedure, Auxiliary liver transplantation, ALPPS, Unresectable colorectal liver metastases, Small-for-size graft, Two-stage hepatectomy, Portal vein ligation, Liver regeneration, Transplant oncology
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPID ProcedureProcedure or surgery
Two-stage surgical procedure combining the principles of ALPPS with auxiliary partial liver transplantation. Stage 1 (Day 0): partial hepatectomy to remove the tumor-bearing liver portion, orthotopic implantation of a small-for-size graft (living donor left lateral segments or split deceased-donor left lateral segments), and ligation of the portal vein supplying the preserved native liver; the corresponding hepatic artery is preserved. Interstage monitoring includes liver function tests, Doppler ultrasound, and CT/MRI volumetry. Stage 2: completion hepatectomy of the remnant native liver once the graft has achieved adequate volume and function.
| Study group | Role | What they receive |
|---|---|---|
| RAPID Procedure | Experimental | All enrolled participants receive the RAPID procedure, a two-stage surgical intervention. Stage 1: partial hepatectomy to remove the tumor-bearing portion of the liver, preserving the remaining native liver as temporary metabolic support; orthotopic implantation of a small-for-size liver graft; ligation of the portal vein supplying the preserved native liver to redirect portal flow to the graft, with preservation of the hepatic artery supplying the preserved native liver. Stage 2: completion hepatectomy to remove the remnant native liver after adequate graft hypertrophy (graft GRWR ≥0.8% and MDT confirmation). Receives: Procedure: RAPID Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Tumor Event-Free Survival Rate
Proportion of participants alive and free of tumor progression or recurrence at 2 years after Stage 1 surgery. A tumor event is defined as tumor progression or recurrence confirmed by imaging (CT/MRI/PET-CT) according to RECIST 1.1 or by pathology, or death from any cause, whichever occurs first. Participants who fail to complete Stage 2 surgery are counted as having an event from the date of Stage 2 failure, regardless of whether tumor progression has occurred. Participants last known to be alive and event-free are censored at the date of last follow-up.
Measured: From Stage 1 surgery to tumor progression, recurrence, or death from any cause, assessed up to 2 years after Stage 1 surgery
Secondary outcomes (2)
Incidence of Major Perioperative Complications (Clavien-Dindo Grade ≥IIIa)
Proportion of participants experiencing Clavien-Dindo grade ≥IIIa complications from Stage 1 surgery through 90 days after Stage 2 surgery. Grade IIIa indicates complications requiring surgical, endoscopic, or radiological intervention without general anesthesia; grade IIIb requires intervention under general anesthesia; grade IV indicates life-threatening organ dysfunction requiring ICU management; grade V indicates death. Complications are recorded by type (e.g., primary graft non-function, small-for-size syndrome, biliary complications, vascular complications, bleeding, infection, renal failure requiring replacement therapy, respiratory failure requiring mechanical ventilation).
Measured: From Stage 1 surgery through 90 days after Stage 2 surgery
Stage 2 Completion Rate
Proportion of participants who successfully complete Stage 2 completion hepatectomy among all participants who undergo Stage 1 surgery. The decision to proceed to Stage 2 is made by the multidisciplinary team based on graft volume growth (target GRWR ≥0.8% or graft volume doubling) and recovery of liver function. Participants who do not proceed to Stage 2 by Day 42 after Stage 1, or who discontinue the surgical pathway due to tumor progression or persistent graft dysfunction, are counted as not completing Stage 2.
Measured: From Stage 1 surgery until Stage 2 completion or up to Day 42 after Stage 1 surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver Metastases (CRCLM)Studies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive the RAPID procedure (Stage 1 partial hepatectomy with implantation of a small-for-size liver graft and portal inflow modulation; Stage 2 completion hepatectomy after adequate graft hypertrophy). There is no comparator group.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Liu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919951
- Sponsor's protocol ID
- SYS-RAPID-0001
- Acronym
- RAPID-uCRLM
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nadalin S, Konigsrainer A, Capobianco I, Settmacher U, Rauchfuss F. Auxiliary living donor liver transplantation combined with two-stage hepatectomy for unresectable colorectal liver metastases. Curr Opin Organ Transplant. 2019 Oct;24(5):651-658. doi: 10.1097/MOT.0000000000000695.
PubMed 31397729RAPID Consensus ISLS 2023 Zurich Collaborative; Chairs; Scientific Committee; Jury Members; Administration Committee; Writing Committee; Expert Panels; Scientific Liaison - Rapid Nomenclature; Panel Members; Scientific Liaison - Preoperative Assessment; Panel Members; Scientific Liaison - Graft Selection; Panel Members; Scientific Liaison - Surgical Technique; Panel Members; Scientific Liaison - Hepatic Hemodynamics; Panel Members; Scientific Liaison - Native Liver Removal; Panel Members; Scientific Liaison - Small for Size; Panel Members; Scientific Liaison - Registries; Panel Members; RAPID Consensus ISLS 2023 Zurich Collaborative and Chairs and Scientific Committee and Jury Members and Administration Committee and Writing Committee and Expert Panels and Scientific Liaison - Rapid Nomenclature and Panel Members and Scientific Liaison - Preoperative Assessment and Panel Members and Scientific Liaison - Graft Selection and Panel Members and Scientific Liaison - Surgical Technique and Panel Members and Scientific Liaison - Hepatic Hemodynamics and Panel Members and Scientific Liaison - Native Liver Removal and Panel Members and Scientific Liaison - Small for Size and Panel Members and Scientific Liaison - Registries and Panel Members. International consensus recommendations for the RAPID procedure in liver transplantation: The RAPID Consensus ISLS 2023 Zurich Collaborative. Int J Surg. 2025 Apr 1;111(4):2766-2772. doi: 10.1097/JS9.0000000000002145.
PubMed 39907624
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the RAPID Procedure (Resection and Partial Liver Transplantation With Delayed Total Hepatectomy) for Unresectable Colorectal Liver Metastases: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07919951
- Acronym / sponsor ID
- RAPID-uCRLM / SYS-RAPID-0001
- Keywords
- RAPID procedure, Auxiliary liver transplantation, ALPPS, Unresectable colorectal liver metastases, Small-for-size graft, Two-stage hepatectomy, Portal vein ligation, Liver regeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 5 Nov 2026 (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.
The goal of this clinical trial is to learn if the RAPID procedure works to treat colorectal cancer that has spread to the liver and cannot be removed by surgery. It will also learn about the safety of the procedure. The main questions it aims to answer are:
- How many participants are alive without the cancer progressing or returning 2 years after the first-stage surgery?
- How many participants complete the second-stage surgery, and how quickly does the liver graft grow between the two stages?
- What medical problems do participants have around the time of surgery, including serious complications?
Participants will:
- Undergo the first-stage surgery: removal of the left part of the liver and implantation of a small liver graft, with the right portal vein tied off to help the graft grow;
- Have blood tests and ultrasound checks after surgery, and regular CT or MRI scans to measure graft growth; (4) Undergo the second-stage surgery to remove the remaining diseased liver once the graft has grown enough (5) Visit the clinic every 3 months for up to 2 years after the second-stage surgery for checkups, imaging, and blood tests to see if the cancer has returned
Detailed description
This is a prospective clinical trial evaluating the RAPID procedure (Resection and Partial Liver Transplantation with Delayed Total Hepatectomy) in patients with unresectable colorectal liver metastases (uCRLM).
Stage 1 is performed on Day 0: partial hepatectomy is carried out to remove the tumor-bearing portion of the liver, preserving the remaining native liver as temporary metabolic support. A small-for-size graft is implanted orthotopically. The portal vein supplying the preserved native liver is ligated to redirect portal flow to the graft, while the hepatic artery supplying the preserved native liver is preserved.
Interstage monitoring begins on postoperative Day 1. Liver function (TBIL, INR, ALT, AST) and graft blood flow (Doppler ultrasound) are assessed. Graft volume is measured by CT/MRI volumetry on postoperative Days 7 and 14, and every 7 days thereafter. The criteria for proceeding to Stage 2 (all must be met) are: graft GRWR ≥0.8%, and multidisciplinary team (MDT) confirmation that Stage 2 surgery can proceed. The first formal assessment is on postoperative Day 7.
Stage 2 is performed once the criteria are met: the remnant native liver is removed, and the graft is preserved.
Postoperative follow-up continues for up to 2 years after Stage 2 (with exploratory extension to 5 years), with visits every 3 months. Assessments include history and physical examination, ECOG status, liver function, CEA/CA19-9, contrast-enhanced CT of the chest and abdomen. Tumor progression or recurrence is adjudicated by an independent imaging reviewer. The primary endpoint is the 2-year tumor event-free survival rate, defined as the time from Stage 1 surgery to tumor progression, recurrence, or death from any cause, whichever occurs first.
This response is AI-generated, for reference only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the RAPID procedure (Stage 1 partial hepatectomy with implantation of a small-for-size liver graft and portal inflow modulation; Stage 2 completion hepatectomy after adequate graft hypertrophy). There is no comparator group.
| Arm | Type | Receives |
|---|---|---|
| RAPID Procedure | Experimental | Procedure: RAPID ProcedureAll enrolled participants receive the RAPID procedure, a two-stage surgical intervention. Stage 1: partial hepatectomy to remove the tumor-bearing portion of the liver, preserving the remaining native liver as temporary metabolic support; orthotopic implantation of a small-for-size liver graft; ligation of the portal vein supplying the preserved native liver to redirect portal flow to the graft, with preservation of the hepatic artery supplying the preserved native liver. Stage 2: completion hepatectomy to remove the remnant native liver after adequate graft hypertrophy (graft GRWR ≥0.8% and MDT confirmation). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 65 years; ECOG performance status 0 to 1.
- Histologically confirmed colorectal adenocarcinoma; primary tumor radically resected, or resectable synchronously or in a staged manner.
- Unresectable colorectal liver metastases as assessed by a multidisciplinary team (hepatobiliary surgery, medical oncology, radiology).
- No unresectable extrahepatic metastases.
- Received standard chemotherapy plus targeted therapy, with stable disease.
Key exclusion criteria (8 listed)
- Unresectable extrahepatic metastases (resectable pulmonary nodules are permitted).
- Primary colorectal tumor not amenable to radical resection.
- BRAF V600E mutation or microsatellite instability-high (MSI-H).
- Severe hepatic insufficiency (Child-Pugh class B or C), or clinically significant portal hypertension.
- Severe cardiopulmonary or renal insufficiency, or judged by the surgeon to be unable to tolerate two-stage major surgery.
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 |
|---|---|---|
| RAPID ProcedureTwo-stage surgical procedure combining the principles of ALPPS with auxiliary partial liver transplantation. Stage 1 (Day 0): partial hepatectomy to remove the tumor-bearing liver portion, orthotopic implantation of a small-for-size graft (living donor left lateral segments or split deceased-donor left lateral segments), and ligation of the portal vein supplying the preserved native liver; the corresponding hepatic artery is preserved. Interstage monitoring includes liver function tests, Doppler ultrasound, and CT/MRI volumetry. Stage 2: completion hepatectomy of the remnant native liver once the graft has achieved adequate volume and function. | Procedure or surgery | RAPID Procedure |
Primary outcome
2-Year Tumor Event-Free Survival Rate
Time frame: From Stage 1 surgery to tumor progression, recurrence, or death from any cause, assessed up to 2 years after Stage 1 surgery
Proportion of participants alive and free of tumor progression or recurrence at 2 years after Stage 1 surgery. A tumor event is defined as tumor progression or recurrence confirmed by imaging (CT/MRI/PET-CT) according to RECIST 1.1 or by pathology, or death from any cause, whichever occurs first. Participants who fail to complete Stage 2 surgery are counted as having an event from the date of Stage 2 failure, regardless of whether tumor progression has occurred. Participants last known to be alive and event-free are censored at the date of last follow-up.
2 secondary outcomes
Incidence of Major Perioperative Complications (Clavien-Dindo Grade ≥IIIa)
Time frame: From Stage 1 surgery through 90 days after Stage 2 surgery
Stage 2 Completion Rate
Time frame: From Stage 1 surgery until Stage 2 completion or up to Day 42 after Stage 1 surgery
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 5 Nov 2026.
- Background: PubMed 31397729Nadalin S, Konigsrainer A, Capobianco I, Settmacher U, Rauchfuss F. Auxiliary living donor liver transplantation combined with two-stage hepatectomy for unresectable colorectal liver metastases. Curr Opin Organ Transplant. 2019 Oct;24(5):651-658. doi: 10.1097/MOT.0000000000000695.
- Background: PubMed 39907624RAPID Consensus ISLS 2023 Zurich Collaborative; Chairs; Scientific Committee; Jury Members; Administration Committee; Writing Committee; Expert Panels; Scientific Liaison - Rapid Nomenclature; Panel Members; Scientific Liaison - Preoperative Assessment; Panel Members; Scientific Liaison - Graft Selection; Panel Members; Scientific Liaison - Surgical Technique; Panel Members; Scientific Liaison - Hepatic Hemodynamics; Panel Members; Scientific Liaison - Native Liver Removal; Panel Members; Scientific Liaison - Small for Size; Panel Members; Scientific Liaison - Registries; Panel Members; RAPID Consensus ISLS 2023 Zurich Collaborative and Chairs and Scientific Committee and Jury Members and Administration Committee and Writing Committee and Expert Panels and Scientific Liaison - Rapid Nomenclature and Panel Members and Scientific Liaison - Preoperative Assessment and Panel Members and Scientific Liaison - Graft Selection and Panel Members and Scientific Liaison - Surgical Technique and Panel Members and Scientific Liaison - Hepatic Hemodynamics and Panel Members and Scientific Liaison - Native Liver Removal and Panel Members and Scientific Liaison - Small for Size and Panel Members and Scientific Liaison - Registries and Panel Members. International consensus recommendations for the RAPID procedure in liver transplantation: The RAPID Consensus ISLS 2023 Zurich Collaborative. Int J Surg. 2025 Apr 1;111(4):2766-2772. doi: 10.1097/JS9.0000000000002145.
- Individual participant dataSharing planned: Undecided
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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 RAPID Procedure in people with Colorectal Liver Metastases (CRCLM) and Colorectal Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 8 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 5 Nov 2026. 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 Li PANG, PhD (+86 13622860325, pangli5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Tumor Event-Free Survival Rate (time frame: From Stage 1 surgery to tumor progression, recurrence, or death from any cause, assessed up to 2 years after Stage 1 surgery). 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 NCT07919951, which also lists 2 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 5 Nov 2026.