Advanced Biliary Tract CarcinomaPhase 2NCT04550624
Pembrolizumab in Combination With Lenvatinib in Patients With Advanced Biliary Tract Carcinoma
A Phase 2 study testing Pembrolizumab Injection [Keytruda] and Lenvatinib Mesylate in people with Advanced Biliary Tract Carcinoma, run by Shanghai Jiahui International Hospital at 2 sites in China.
Trial summary
The prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Tract Carcinoma
- What is being tested?
- Pembrolizumab Injection [Keytruda] and Lenvatinib Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2021to 2 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following criteria in order to be eligible to participate in the study:
- Unresectable or metastatic, histologically-confirmed advanced BTC (excluding periampullary cancer)
- Failed standard systemic therapy for advanced BTC due to progression of disease or toxicity
- Measurable disease
- Prior chemoembolization, radiofrequency ablation, or radiation to the liver is allowed as long as the patient has measurable disease outside the chemoembolization or radiation area or measurable progression at the site of chemoembolization or radiation
- ECOG Performance status ≤ 1
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- Life expectancy > 3 months
- Adequate renal function as defined by Cr ≤ 1.5 upper limit of normal (ULN) or glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2
- Adequate hepatic function as defined by bilirubin ≤ 2.5 x ULN and alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5x ULN
- Adequate bone marrow reserve as evidenced by ANC > 1500/mcl, Plts >75,000/mcl, Hgb ≥ 9.0g/dl
- Prothrombin time / Partial thromboplastin time (PT/PTT) <1.5x ULN
- Urine Protein: Creatinine ratio of <1, if protein is > 2+ on urinalysis
- Age ≥ 18 years
- Participants with past or ongoing hepatitis C virus (HCV) infection are eligible for the study. Treated participants must have completed their treatment at least 1 month prior to starting study intervention. Untreated or incompletely treated HCV participants may initiate anti-viral therapy for HCV if liver function remains stable for at least 3 months on study intervention
- Participants with controlled hepatitis B are eligible for the study, as long as they meet the following criteria:
- Participants with chronic hepatitis B virus (HBV) infection, defined as HBsAg positive and/or detectable HBV DNA, must be given antiviral therapy for HBV for at least 4 weeks prior to the first dose of study intervention and HBV viral load must be less than 100 IU/ml. prior to the first dose of study treatment. Participants on active HBV therapy with viral loads under 100 IU/ml. should stay on the same therapy throughout study intervention. Antiviral therapy after completion of study intervention should follow local guidelines.
- Participants with clinically resolved HBV infection, defined as HBsAg negative and anti-hepatitis B core antigen (HBc) positive, and who have an undetectable HBV viral load at screening should be checked every 6 weeks for HBV viral load and treated for HBV if viral load is over 100 IU/ml. Antiviral therapy after completion of study intervention should follow local guidelines.
Who cannot join
- Patients who exhibit any of the following conditions at screening will not be eligible to be enrolled to the study:
- Prior treatment with other VEGF-R directed therapies
- Periampullary cancer
- Major surgery or radiation within the 4 weeks prior to enrollment; is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of registration. The treated patients must recover from their relevant treatment(i.e. to≤1 grade or baseline) and from any AEs caused by any previous treatment
- Uncontrolled hypertension defined by systolic blood pressure (SBP)>150 or diastolic blood pressure (DBP)>90 despite titration of anti-hypertensive medications
- Active, known or suspected autoimmune disease
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- Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
- Cerebrovascular accident within prior 6 months
- Clinically significant hemorrhage, bleeding event, or thromboembolic disease within six months
- History of bowel perforation
- History of (non-infectious) pneumonitis that required steroids or currently has pneumonitis
- Known history of HIV infection
- Severely impaired lung function or history of interstitial lung disease
- Concurrent malignancy (other than adequately treated non-melanoma skin cancer, superficial transitional cell carcinoma of the bladder, and cervical CIS) diagnosed within the past 5 years or any currently active malignancy
- Positive serum pregnancy test within 72 hours of first dosing of study treatment
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Jiahui International Hospital
Shanghai, Shanghai Municipality, 200233
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: A Single Arm Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With Advanced Biliary Tract Carcinoma After Progression on Standard Systemic Therapy
The prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. There is no standard second- or third-line therapy for advanced BTC, and this represents an unmet medical need for novel therapies. The immune system plays a critical role in the development of Advanced Biliary Tract Carcinoma (BTC) and chronic inflammation is a common underlying risk factor for BTC. Vascular endothelial growth factor (VEGF) signaling in BTC may lead to an immune suppression via inadequate tumor antigen presentation and an impaired T cell-mediated immune response directed against tumor antigens. Lenvatinib significantly decreased the population of immunosuppressive tumor-associated macrophages and increased interferon-γ-producing cluster of differentiation 8+ (CD8+) T cells. Addition of programmed cell death protein 1 (PD-1)/programmed death-ligand (PD-L1) inhibitors helps reverse VEGF-mediated immune suppression, restore T cell function, and promote T cell tumor infiltration. The combination of lenvatinib and pembrolizumab has demonstrated promising activity with manageable adverse events in various solid tumor types.
The investigators will assess the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with advanced BTC who failed standard therapy in this phase II study.
Read the detailed description
Title: A Single Arm Phase II Study of Pembrolizumab in combination with Lenvatinib in Patients with Advanced Biliary Tract Carcinoma after Progression on Standard Systemic Therapy Study Description: The prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. There is no standard second- or third-line therapy for advanced BTC, and this represents an unmet medical need for novel therapies. The immune system plays a critical role in the development of Advanced Biliary Tract Carcinoma (BTC) and chronic inflammation is a common underlying risk factor for BTC. VEGF signaling in BTC may lead to an immune suppression via inadequate tumor antigen presentation and an impaired T cell-mediated immune response directed against tumor antigens. Lenvatinib significantly decreased the population of immunosuppressive tumor-associated macrophages and increased interferon-γ-producing CD8+ T cells. Addition of PD-1/PD-L1 inhibitors helps reverse VEGF-mediated immune suppression, restore T cell function, and promote T cell tumor infiltration. The combination of lenvatinib and pembrolizumab has demonstrated promising activity with manageable adverse events in various solid tumor types.
The investigators will assess the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with advanced BTC who failed standard therapy in this phase II study.
Objectives and Endpoints:
Primary Objective: Evaluate the objective response rate (ORR) (RECIST1.1) of lenvatinib in combination with pembrolizumab in patients with advanced BTC after progression on standard systemic therapies Secondary Objective: Evaluate the safety and tolerability of lenvatinib+pembrolizumab in this population; Determine the duration of response (DOR), progression free survival (PFS), and overall survival (OS); Determine the ORR, PFS and OS of subgroups stratified by molecular signatures (tumor mutation burden, PD-L1 expression, microsatellite instability (MSI) status, isocitrate dehydrogenase (IDH) or FGFR mutation/fusion status) in a pre-planned post-hoc analysis; Define molecular correlates of response, including circulating biomarkers and tumor tissue biomarkers Study Population: The study will enroll 40 patients who have unresectable or metastatic, histologically-confirmed advanced BTC. Both male and female patients age of 18 years or older who have failed standard systemic therapy for advanced BTC with measurable disease, adequate bone marrow reserve and hepatic/renal function, and ECOG performance status (PS) 0-1 could be eligible to participate in the study after completing the study enrollment screening tests and procedures.
Phase: II Description of Sites/Facilities Enrolling Participants: The study will be conducted at Jiahui International Cancer Center, Shanghai Jiahui International Hospital, in collaboration with Zhongshan Hospital.
Study treatment/Intervention: Each cycle is defined as 21 days treatment of Pembrolizumab in combination with Lenvatinib. Treatment will be administered on an outpatient basis:
Pembrolizumab 200mg IV day 1 of every 21 day-cycles; Lenvatinib 20mg PO once daily for 21-day cycles Study Duration: 24-36 months Participant Duration: up to 24 months
- Conditions
- Advanced Biliary Tract Carcinoma
- Being tested
- Pembrolizumab Injection [Keytruda], Lenvatinib Mesylate
- Keywords
- Advanced Biliary Tract Carcinoma, Pembrolizumab, Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab Injection [Keytruda]Drug
Also called Keytruda
200mg IV on day 1 of each cycle
Lenvatinib MesylateDrug
Also called Lenvima
20mg PO daily days 1-21 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | This is an open-label, multi-center, phase II trial of lenvatinib in combination with pembrolizumab in patients with Advanced Biliary Tract Carcinoma (BTC) who have progressed on standard systemic therapy. All participants will be administered Pembrolizumab 200mg IV on day 1 and Lenvatinib 20mg PO daily days 1-21 of each cycle (21 days). Receives: Drug: Pembrolizumab Injection [Keytruda]; Drug: Lenvatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ORR
Evaluate the objective response rate (ORR) (RECIST1.1) of lenvatinib in combination with pembrolizumab in patients with advanced BTC after progression on standard systemic therapies
Measured: up to 36 months
Secondary outcomes (7)
All participants who receive at least one dose of study treatment will be evaluable for safety and tolerability through the monitoring of serious and non serious AEs, defined and graded according to NCI CTCAE v5.0.
All participants who receive at least one dose of study treatment will be evaluable for safety and tolerability in this study through the monitoring of all serious and non serious AEs, defined and graded according to NCI CTCAE v5.0 from the time of their first treatment.
Measured: up to 36 months
Duration of Overall Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. Patients who do not relapse will be censored at the day of their last tumor assessment.
Measured: up to 36 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of objective disease progression or death from any cause without evidence of disease progression, whichever comes first.
Measured: up to 36 months
Overall Survival (OS)
Overall Survival (OS) is defined as the duration of time from start of treatment to time of death.
Measured: up to 36 months
Objective Response Rate (ORR) of subgroups burden
Determine the ORR of subgroups stratified by molecular signatures (tumor mutation burden, PD-L1 expression, MSI status, FGFR mutation/fusion status) in a pre-planned post-hoc analysis
Measured: up to 36 months
Progression-Free Survival (PFS) of subgroups burden
Determine the PFS of subgroups stratified by molecular signatures (tumor mutation burden, PD-L1 expression, MSI status, FGFR mutation/fusion status) in a pre-planned post-hoc analysis
Measured: up to 36 months
Overall Survival (OS) of subgroups burden
Determine the OS of subgroups stratified by molecular signatures (tumor mutation burden, PD-L1 expression, MSI status, FGFR mutation/fusion status) in a pre-planned post-hoc analysis
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start15 Sep 2021
- Primary completion18 Jul 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiahui International Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Andrew Zhu, PhD, Principal investigator, Shanghai JIH international Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550624
- Sponsor's protocol ID
- 2020-0001
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2020
- Last updated
- 21 Jan 2026
- Results posted
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With Advanced Biliary Tract Carcinoma After Progression on Standard Systemic Therapy
- ClinicalTrials.gov ID
- NCT04550624
- Acronym / sponsor ID
- 2020-0001
- Conditions
- Advanced Biliary Tract Carcinoma
- Keywords
- Advanced Biliary Tract Carcinoma, Pembrolizumab, Lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Shanghai Jiahui International HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 16 Sep 2020 (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 prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. There is no standard second- or third-line therapy for advanced BTC, and this represents an unmet medical need for novel therapies. The immune system plays a critical role in the development of Advanced Biliary Tract Carcinoma (BTC) and chronic inflammation is a common underlying risk factor for BTC. Vascular endothelial growth factor (VEGF) signaling in BTC may lead to an immune suppression via inadequate tumor antigen presentation and an impaired T cell-mediated immune response directed against tumor antigens. Lenvatinib significantly decreased the population of immunosuppressive tumor-associated macrophages and increased interferon-γ-producing cluster of differentiation 8+ (CD8+) T cells. Addition of programmed cell death protein 1 (PD-1)/programmed death-ligand (PD-L1) inhibitors helps reverse VEGF-mediated immune suppression, restore T cell function, and promote T cell tumor infiltration. The combination of lenvatinib and pembrolizumab has demonstrated promising activity with manageable adverse events in various solid tumor types.
The investigators will assess the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with advanced BTC who failed standard therapy in this phase II study.
Detailed description
Title: A Single Arm Phase II Study of Pembrolizumab in combination with Lenvatinib in Patients with Advanced Biliary Tract Carcinoma after Progression on Standard Systemic Therapy Study Description: The prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. There is no standard second- or third-line therapy for advanced BTC, and this represents an unmet medical need for novel therapies. The immune system plays a critical role in the development of Advanced Biliary Tract Carcinoma (BTC) and chronic inflammation is a common underlying risk factor for BTC. VEGF signaling in BTC may lead to an immune suppression via inadequate tumor antigen presentation and an impaired T cell-mediated immune response directed against tumor antigens. Lenvatinib significantly decreased the population of immunosuppressive tumor-associated macrophages and increased interferon-γ-producing CD8+ T cells. Addition of PD-1/PD-L1 inhibitors helps reverse VEGF-mediated immune suppression, restore T cell function, and promote T cell tumor infiltration. The combination of lenvatinib and pembrolizumab has demonstrated promising activity with manageable adverse events in various solid tumor types.
The investigators will assess the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with advanced BTC who failed standard therapy in this phase II study.
Objectives and Endpoints:
Primary Objective: Evaluate the objective response rate (ORR) (RECIST1.1) of lenvatinib in combination with pembrolizumab in patients with advanced BTC after progression on standard systemic therapies Secondary Objective: Evaluate the safety and tolerability of lenvatinib+pembrolizumab in this population; Determine the duration of response (DOR), progression free survival (PFS), and overall survival (OS); Determine the ORR, PFS and OS of subgroups stratified by molecular signatures (tumor mutation burden, PD-L1 expression, microsatellite instability (MSI) status, isocitrate dehydrogenase (IDH) or FGFR mutation/fusion status) in a pre-planned post-hoc analysis; Define molecular correlates of response, including circulating biomarkers and tumor tissue biomarkers Study Population: The study will enroll 40 patients who have unresectable or metastatic, histologically-confirmed advanced BTC. Both male and female patients age of 18 years or older who have failed standard systemic therapy for advanced BTC with measurable disease, adequate bone marrow reserve and hepatic/renal function, and ECOG performance status (PS) 0-1 could be eligible to participate in the study after completing the study enrollment screening tests and procedures.
Phase: II Description of Sites/Facilities Enrolling Participants: The study will be conducted at Jiahui International Cancer Center, Shanghai Jiahui International Hospital, in collaboration with Zhongshan Hospital.
Study treatment/Intervention: Each cycle is defined as 21 days treatment of Pembrolizumab in combination with Lenvatinib. Treatment will be administered on an outpatient basis:
Pembrolizumab 200mg IV day 1 of every 21 day-cycles; Lenvatinib 20mg PO once daily for 21-day cycles Study Duration: 24-36 months Participant Duration: up to 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: Pembrolizumab Injection [Keytruda], Drug: Lenvatinib MesylateThis is an open-label, multi-center, phase II trial of lenvatinib in combination with pembrolizumab in patients with Advanced Biliary Tract Carcinoma (BTC) who have progressed on standard systemic therapy. All participants will be administered Pembrolizumab 200mg IV on day 1 and Lenvatinib 20mg PO daily days 1-21 of each cycle (21 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must meet the following criteria in order to be eligible to participate in the study:
- Participants with chronic hepatitis B virus (HBV) infection, defined as HBsAg positive and/or detectable HBV DNA, must be given antiviral therapy for HBV for at least 4 weeks prior to the first dose of study intervention and HBV viral load must be less than 100 IU/ml. prior to the first dose of study treatment. Participants on active HBV therapy with viral loads under 100 IU/ml. should stay on the same therapy throughout study intervention. Antiviral therapy after completion of study intervention should follow local guidelines.
Key exclusion criteria (16 listed)
- Patients who exhibit any of the following conditions at screening will not be eligible to be enrolled to the study:
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 |
|---|---|---|
| Pembrolizumab Injection [Keytruda]Also: Keytruda200mg IV on day 1 of each cycle | Drug | Interventional Arm |
| Lenvatinib MesylateAlso: Lenvima20mg PO daily days 1-21 of each cycle | Drug | Interventional Arm |
Primary outcome
Evaluation of ORR
Time frame: up to 36 months
Evaluate the objective response rate (ORR) (RECIST1.1) of lenvatinib in combination with pembrolizumab in patients with advanced BTC after progression on standard systemic therapies
7 secondary outcomes
All participants who receive at least one dose of study treatment will be evaluable for safety and tolerability through the monitoring of serious and non serious AEs, defined and graded according to NCI CTCAE v5.0.
Time frame: up to 36 months
Duration of Overall Response (DOR)
Time frame: up to 36 months
Progression-Free Survival (PFS)
Time frame: up to 36 months
Overall Survival (OS)
Time frame: up to 36 months
Objective Response Rate (ORR) of subgroups burden
Time frame: up to 36 months
Progression-Free Survival (PFS) of subgroups burden
Time frame: up to 36 months
Overall Survival (OS) of subgroups burden
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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.
Andrew Zhu, PhD principal investigator
Shanghai JIH international Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab Injection [Keytruda] and Lenvatinib Mesylate in people with Advanced Biliary Tract Carcinoma, run by Shanghai Jiahui International Hospital at 2 sites 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 17 inclusion and 16 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of ORR (time frame: up to 36 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 21 Jan 2026.