Hepatocellular Carcinoma (HCC)Phase 2NCT03510871
Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)
A Phase 2 study testing nivolumab, ipilimumab in people with Hepatocellular Carcinoma (HCC), run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
Trial summary
Objectives: 1. To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC; 2. To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment; 3. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- nivolumab, ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 8 sitesTaiwan
- Study dates
- 12 Feb 2019to 31 May 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of HCC with potential for curative surgical resection fulfilling one of the following criteria:
- (A)Tumor(s) with macrovascular invasion. (B)Tumors with one of the following features: (B1)multiple tumors and bilateral lobes involvement, none more than 5 cm (B2)tumor number > 3, none more than 5 cm (B3)multiple tumors none more than 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL) (B4)solitary tumor > 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL) (B5)Other conditions that are considered high-risk for recurrence after surgery, e.g., direct diaphragmic invasion suspected by imaging。
- No evidence of extra-hepatic metastases.
- At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
- Prior percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy are allowed if aforementioned local therapy is given at least 4 weeks prior to enrollment and progressive or recurrent disease is documented.
- Age >= 20 years old.
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- ECOG performance status 0 or 1.
- Child-Pugh class A liver function.
- WBC >=2,000/uL (stable, off any growth factor within 4 weeks of study drug administration) ; Platelet>= 60,000/uL.
- Liver transaminases (ALT and AST) <= 5 times upper limit of normal values (ULN); total bilirubin <=1.5 times ULN; serum creatinine<=1.5 times ULN; creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault formula)
- Subjects with chronic hepatitis B virus infection (HBV surface antigen (HBsAg) positive) must start antiviral therapy with nucleoside analogs (e.g., entecavir or tenofovir, according to current practice guidelines) before start of study drug treatment.
- Signed informed consent.
Who cannot join
- Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, systemic therapy, or other experimental therapy.
- Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, or transarterial embolization administered within 4 weeks prior to enrollment.
- Major surgical procedure within 2 weeks or minor surgical procedure within 1 week prior to enrollment.
- History of esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding.
- History of upper gastrointestinal bleeding within 1 year.
- Known human immunodeficiency virus (HIV) infection.
Show all 14Show fewer
- Major systemic diseases that the investigator considers inappropriate for participation.
- History of other malignancies except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
- Any active autoimmune disease or history of known autoimmune disease except for vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
- Requirement of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Prior organ allograft or allogeneic bone marrow transplantation.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Chang-Gung Memorial Hospital, Kaohsiung
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng-Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang-Gung Memorial Hospital, Linkou
Taoyuan
About this study
Objectives:
- To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC;
- To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment;
- To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.
Read the detailed description
Immune checkpoint inhibitor therapy represents the major breakthrough of anticancer drug therapy development in recent years. Inhibitors targeting the cytotoxic T-lymphocyte antigen 4 (CTLA-4) or the programmed death-1 (PD-1) checkpoints have shown antitumor activity in multiple cancer types. Combination of anti-CTLA-4 and anti-PD-1 therapy may increase the objective response rate for patients with advanced cancers and thus may further improve the treatment efficacy. The anti-PD-1 drug nivolumab recently got approval by US FDA for the treatment of advanced hepatocellular carcinoma (HCC) patients who have been treated with sorafenib. Preliminary data also suggested that combination of nivolumab and anti-CTLA-4 therapy could increase the objective response rate for advanced HCC, with a better safety profile compared with conventional combination therapies (cytotoxic chemotherapy or molecular targeted therapy). This project aims to explore whether the high response rate produced by the combination of anti-PD-1 and anti-CTLA-4 may improve the treatment efficacy of HCC patients who are potentially eligible for curative surgery.
This is a single-arm, open-label trial. Eligible subjects must have histological diagnosis of HCC and fulfilling one of the following criteria of 'potentially eligible for curative surgery': (a) AJCC T3 tumor(s) (tumor with macrovascular invasion); (b) AJCC T2 tumors with multiple tumors and bilateral lobes involvement, none more than 5 cm; (c) AJCC T2 tumors with tumor number > 3, none more than 5 cm; (d) AJCC T2 tumors with multiple tumors none more than 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL); or (e) solitary tumor > 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL) ; (f) Other conditions that are considered high-risk for recurrence after surgery, e.g., direct diaphragmic invasion suspected by imaging。Eligible subjects must have ECOG performance status 0 or 1, Child-Pugh class A liver function, and measurable tumors (by RECIST 1.1). All enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles). Subjects who are considered eligible for curative surgery will receive surgery, while those considered not eligible for surgery will receive other anti-cancer therapy according to current practice guidelines (e.g., trans-catheter arterial chemoembolization). Samples will be collected from the subjects' tumor tissue, peripheral blood, and stool for studies of immune biomarkers.
The primary endpoint is the percentage of subjects with tumor shrinkage (> 10% of decrease of the sum of the target lesions according to RECIST 1.1) after study drug treatment. It is estimated that about 30-50% subjects may have tumor shrinkage after 2-4 cycles of nivolumab + ipilimumab treatment. With type 1 error 0.05；power=0.9，P0=0.30, P1=0.55 respectively, 40 evaluable subjects (subjects who receive at least 2 cycles of study drug treatment and receive the first scheduled assessment of tumor response, assuming a 10% dropout rate) will be required. The study is expected to complete enrollment in 2 years.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- nivolumab, ipilimumab
- Keywords
- neoadjuvant therapy, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumab, ipilimumabDrug
Also called nivolumab plus ipilimumab
All enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles).
| Study group | Role | What they receive |
|---|---|---|
| nivolumab plus ipilimumab | Experimental | nivolumab plus ipilimumab Receives: Drug: nivolumab, ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of subjects with tumor shrinkage after study drug treatment
> 10% of decrease of the sum of the target lesions according to RECIST 1.1
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start12 Feb 2019
- Primary completion31 May 2024
- Study completion31 May 2024
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 Hepatocellular Carcinoma (HCC)Studies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, National Cheng-Kung University Hospital, China Medical University Hospital, Chang Gung Memorial Hospital, Mackay Memorial Hospital, Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Tsang-Wu Liu, MD, PhD, Study chair, Taiwan Cooperative Oncology Group, NHRIChiun Hsu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510871
- Sponsor's protocol ID
- T2217
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2018
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Invetigator Initial Trial
Publications
Lin YJ, Ou DL, Su YY, Hsu CL, Hsiao CF, Ko BS, Chen SC, Wang HW, Wang JH, Wu YM, Jeng YM, Lee WC, Chou SC, Chen TW, Chiu CF, Lin JS, Hsieh CH, Lee CC, Shan YS, Cheng AL, Chen LT, Hsu C. Nivolumab plus ipilimumab for potentially resectable hepatocellular carcinoma: Long-term efficacy and biomarker exploration. J Hepatol. 2026 Feb;84(2):316-328. doi: 10.1016/j.jhep.2025.08.035. Epub 2025 Sep 17.
PubMed 40972843D'Alessio A, Stefanini B, Blanter J, Adegbite B, Crowley F, Yip V, Slater S, Fulgenzi CAM, Celsa C, Manfredi GF, Pai M, Goldin RD, Ward SC, Fiel MI, Shu DH, Su YY, Cortellini A, Baretti M, Anders R, Yarchoan M, Hsu C, Marron TU, Pinato DJ. Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis. Lancet Oncol. 2024 Nov;25(11):1465-1475. doi: 10.1016/S1470-2045(24)00457-1. Epub 2024 Oct 19.
PubMed 39437804
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT03510871
- Acronym / sponsor ID
- T2217
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- neoadjuvant therapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, National Cheng-Kung University Hospital, China Medical University Hospital, Chang Gung Memorial Hospital, Mackay Memorial Hospital, Tri-Service General Hospital (TSGH)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Apr 2018 (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.
Objectives:
- To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC;
- To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment;
- To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.
Detailed description
Immune checkpoint inhibitor therapy represents the major breakthrough of anticancer drug therapy development in recent years. Inhibitors targeting the cytotoxic T-lymphocyte antigen 4 (CTLA-4) or the programmed death-1 (PD-1) checkpoints have shown antitumor activity in multiple cancer types. Combination of anti-CTLA-4 and anti-PD-1 therapy may increase the objective response rate for patients with advanced cancers and thus may further improve the treatment efficacy. The anti-PD-1 drug nivolumab recently got approval by US FDA for the treatment of advanced hepatocellular carcinoma (HCC) patients who have been treated with sorafenib. Preliminary data also suggested that combination of nivolumab and anti-CTLA-4 therapy could increase the objective response rate for advanced HCC, with a better safety profile compared with conventional combination therapies (cytotoxic chemotherapy or molecular targeted therapy). This project aims to explore whether the high response rate produced by the combination of anti-PD-1 and anti-CTLA-4 may improve the treatment efficacy of HCC patients who are potentially eligible for curative surgery.
This is a single-arm, open-label trial. Eligible subjects must have histological diagnosis of HCC and fulfilling one of the following criteria of 'potentially eligible for curative surgery': (a) AJCC T3 tumor(s) (tumor with macrovascular invasion); (b) AJCC T2 tumors with multiple tumors and bilateral lobes involvement, none more than 5 cm; (c) AJCC T2 tumors with tumor number > 3, none more than 5 cm; (d) AJCC T2 tumors with multiple tumors none more than 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL); or (e) solitary tumor > 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL) ; (f) Other conditions that are considered high-risk for recurrence after surgery, e.g., direct diaphragmic invasion suspected by imaging。Eligible subjects must have ECOG performance status 0 or 1, Child-Pugh class A liver function, and measurable tumors (by RECIST 1.1). All enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles). Subjects who are considered eligible for curative surgery will receive surgery, while those considered not eligible for surgery will receive other anti-cancer therapy according to current practice guidelines (e.g., trans-catheter arterial chemoembolization). Samples will be collected from the subjects' tumor tissue, peripheral blood, and stool for studies of immune biomarkers.
The primary endpoint is the percentage of subjects with tumor shrinkage (> 10% of decrease of the sum of the target lesions according to RECIST 1.1) after study drug treatment. It is estimated that about 30-50% subjects may have tumor shrinkage after 2-4 cycles of nivolumab + ipilimumab treatment. With type 1 error 0.05；power=0.9，P0=0.30, P1=0.55 respectively, 40 evaluable subjects (subjects who receive at least 2 cycles of study drug treatment and receive the first scheduled assessment of tumor response, assuming a 10% dropout rate) will be required. The study is expected to complete enrollment in 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nivolumab plus ipilimumab | Experimental | Drug: nivolumab, ipilimumabnivolumab plus ipilimumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological diagnosis of HCC with potential for curative surgical resection fulfilling one of the following criteria:
- (A)Tumor(s) with macrovascular invasion. (B)Tumors with one of the following features: (B1)multiple tumors and bilateral lobes involvement, none more than 5 cm (B2)tumor number > 3, none more than 5 cm (B3)multiple tumors none more than 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL) (B4)solitary tumor > 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL) (B5)Other conditions that are considered high-risk for recurrence after surgery, e.g., direct diaphragmic invasion suspected by imaging。
- No evidence of extra-hepatic metastases.
- At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
- Prior percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy are allowed if aforementioned local therapy is given at least 4 weeks prior to enrollment and progressive or recurrent disease is documented.
Key exclusion criteria (14 listed)
- Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, systemic therapy, or other experimental therapy.
- Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, or transarterial embolization administered within 4 weeks prior to enrollment.
- Major surgical procedure within 2 weeks or minor surgical procedure within 1 week prior to enrollment.
- History of esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding.
- History of upper gastrointestinal bleeding within 1 year.
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 |
|---|---|---|
| nivolumab, ipilimumabAlso: nivolumab plus ipilimumabAll enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles). | Drug | nivolumab plus ipilimumab |
Primary outcome
the percentage of subjects with tumor shrinkage after study drug treatment
Time frame: 4 years
> 10% of decrease of the sum of the target lesions according to RECIST 1.1
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 8 Jul 2024.
- Derived from this study: PubMed 40972843Lin YJ, Ou DL, Su YY, Hsu CL, Hsiao CF, Ko BS, Chen SC, Wang HW, Wang JH, Wu YM, Jeng YM, Lee WC, Chou SC, Chen TW, Chiu CF, Lin JS, Hsieh CH, Lee CC, Shan YS, Cheng AL, Chen LT, Hsu C. Nivolumab plus ipilimumab for potentially resectable hepatocellular carcinoma: Long-term efficacy and biomarker exploration. J Hepatol. 2026 Feb;84(2):316-328. doi: 10.1016/j.jhep.2025.08.035. Epub 2025 Sep 17.
- Derived from this study: PubMed 39437804D'Alessio A, Stefanini B, Blanter J, Adegbite B, Crowley F, Yip V, Slater S, Fulgenzi CAM, Celsa C, Manfredi GF, Pai M, Goldin RD, Ward SC, Fiel MI, Shu DH, Su YY, Cortellini A, Baretti M, Anders R, Yarchoan M, Hsu C, Marron TU, Pinato DJ. Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis. Lancet Oncol. 2024 Nov;25(11):1465-1475. doi: 10.1016/S1470-2045(24)00457-1. Epub 2024 Oct 19.
- Individual participant dataSharing planned: No. Invetigator Initial Trial
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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.
Tsang-Wu Liu, MD, PhD study chair
Taiwan Cooperative Oncology Group, NHRI
Chiun Hsu, MD, PhD principal investigator
National Taiwan University Hospital
8 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 nivolumab, ipilimumab in people with Hepatocellular Carcinoma (HCC), run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
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 12 inclusion and 14 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. 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?
the percentage of subjects with tumor shrinkage after study drug treatment (time frame: 4 years). 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 NCT03510871, 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 8 Jul 2024.