Liver CanceriPLENTY-pvttNCT05339581
IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation
A study testing intensity-modulated radiotherapy, Pembrolizumab and Sintilimab in people with Liver Cancer and Liver Transplant; Complications, run by RenJi Hospital at 1 site in China.
Trial summary
This is a parallel assigned, open-label, perspective trial studying the safety and efficacy of intensity-modulated radiotherapy (IMRT) combined with PD-1 Blockade and Lenvatinib for Hepatocellular Carcinoma (HCC) with Vp3 Portal Vein Tumor Thrombus (PVTT, Japanese Liver Cancer Study Group classification) before liver… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer, Liver Transplant; Complications, Hepatocellular Carcinoma
- What is being tested?
- intensity-modulated radiotherapy, Pembrolizumab and Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 31 May 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma（exceeding Milan criteria）; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed.
- The maximum diameter of a single tumor ≤9cm. Or the number of tumors ≤3 and the maximum diameter of the largest tumors ≤5cm, and the sum of the maximum diameters of all tumors ≤9cm.
- Vp3 PVTT according to Japanese Vp classification.
- Without lymph node metastasis or extrahepatic metastasis.
- Baseline AFP≥20ng/ mL
- Has an eligibility scan (CT of the chest, triphasic CT scan and MRI of the abdomen) <1 week before the treatment.
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- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
- Has a Child-Pugh A-B7 liver score (5 to 7 points) within 7 days prior to Cycle 1, Day 1.
- Laboratory tests within 7 days prior to Cycle 1, Day 1:
- Neutrophils ≥1.5×109/L
- Hemoglobin ≥8.5g/dL
- Platelets ≥100×109/L,
- Creatinine ≤1.5× upper limit of normal (ULN) and endogenous creatinine clearance ≥50ml/min (standard Cockcroft Gaul formula)
- Total bilirubin ≤3×ULN, ALT≤5×ULN, AST≤5×ULN, INR≤1.7
- Has controlled hepatitis B (HBV-DNA<105IU/ml)
- The estimate time length between enrollment and liver transplantation should be at least 3 months.
- No prior systematic therapy such as immunotherapy, targeted therapy and chemotherapy for HCC.
- No prior local treatment such as TACE, HAIC, radiofrequency ablation or radiotherapy was received within 2 months before enrollment.
- If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).
- No obvious insufficiency of other organs.
- Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on a regimen of anti-hypertensive therapy.
- Patients voluntarily joined the study and signed informed consent with good compliance and follow-up.
Who cannot join
- • Known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant.
- Surgery within the past 6 months.
- Has had esophageal or gastric variceal bleeding within the last 6 months.
- Has clinically apparent ascites on physical examination.
- Has received systematic therapy such as immunotherapy, targeted therapy and chemotherapy for HCC.
- Has received TACE, HAIC, radiofrequency ablation and other local treatments in recent 2 months.
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- Has received liver radiotherapy.
- Has received radiotherapy with grade 4 toxicity.
- Significant history of cardiac disease is not allowed: Congestive heart failure > class II New York Heart Association (NYHA) Myocardial infarction within 6 months prior to registration Serious myocardial dysfunction, defined as scintigraphically (multigated acquisition scan [MUGA], myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF on echocardiogram (ECHO) below the normal limit at the individual institution.
- Has severe hypersensitivity (≥Grade 3) to monoclonal antibody.
- Has an active autoimmune disease that has required systemic treatment (skin diseases that do not require systemic treatment such as vitiligo, psoriasis; type I diabetes, and autoimmune hypothyroidism due to hormone replacement therapy are allowed).
- Patients with other active malignant tumors within 5 years before the first use of the study drug (cured localized tumors such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situ of cervix and carcinoma in situ of breast are allowed).
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has known active tuberculosis within 5 years.
- Has received a live vaccine within 30 days prior to the first dose of study treatment.
- Has received bone-marrow allotransplantation or solid organ transplantation.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.
- Dysphagia or known drug absorption disorder.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
- Conditions considered unsuitable for inclusion by other researchers.
Trial locations and contacts
1 site in 1 country.
Qiang Xia, MD, Ph.D contact
China1 site
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
About this study
Official title: PILOT Study on the Safety and Efficacy of IMRT Combined With PD-1 Blockade and LEnvatinib as Neoadjuvant TherapY for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (Vp3) Before Liver Transplantation（iPLENTY-pvtt）
This is a parallel assigned, open-label, perspective trial studying the safety and efficacy of intensity-modulated radiotherapy (IMRT) combined with PD-1 Blockade and Lenvatinib for Hepatocellular Carcinoma (HCC) with Vp3 Portal Vein Tumor Thrombus (PVTT, Japanese Liver Cancer Study Group classification) before liver transplantation.
Read the detailed description
In most criteria (e.g.Milan, UCSF, Up-to-seven), PVTT remains as an absolute contraindication for liver transplant due to the high rate of recurrence and poor prognosis. Neoadjuvant therapy has induced pathological responses in multiple tumor types and might decrease the risk of postoperative recurrence in HCC. The primary endpoint is the necrosis rate of PVTT and the primary tumor.
Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a regular treatment cycle and Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily. Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.
- Conditions
- Liver Cancer, Liver Transplant; Complications, Hepatocellular Carcinoma, Portal Vein Thrombosis, Radiotherapy; Complications
- Being tested
- intensity-modulated radiotherapy, Pembrolizumab, Sintilimab, Camrelizumab, Tislelizumab
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity-modulated radiotherapyRadiation
Also called IMRT
Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.
PembrolizumabCombination product
Also called Keytruda
Participants receive PD-1 Blockade (Pembrolizumab 200mg，Sintilimab 200mg， Camrelizumab 200mg，Tislelizumab 200mg) 100-200 mg intravenously on day 1 of a regular treatment cycle until >42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until >7 days before liver transplantation.
SintilimabDrug
Also called Tyvyt
Sintilimab is a recombinant anti-human PD-1 monoclonal antibody.
CamrelizumabDrug
Also called AiRuiKa
Camrelizumab is a humanized anti-human PD-1 monoclonal antibody.
TislelizumabDrug
Tislelizumab is a recombinant anti-human PD-1 monoclonal antibody.
Lenvatinib Mesylate CapsuleDrug
Also called LENVIMA
Lenvatinib (Lenvima®, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.
| Study group | Role | What they receive |
|---|---|---|
| IMRT combined with PD-1 Blockade and Lenvatinib | Experimental | Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a 21-day treatment cycle until >42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until >7 days before liver transplantation.
Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk. Receives: Radiation: intensity-modulated radiotherapy; Combination Product: Pembrolizumab; Drug: Sintilimab; Drug: Camrelizumab; Drug: Tislelizumab; Drug: Lenvatinib Mesylate Capsule |
| PD-1 Blockade and Lenvatinib | Active comparator | Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a 21-day treatment cycle until >42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until >7 days before liver transplantation. Receives: Combination Product: Pembrolizumab; Drug: Sintilimab; Drug: Camrelizumab; Drug: Tislelizumab; Drug: Lenvatinib Mesylate Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVTT RR/NR
Portal vein tumor thrombus related Response and Necrosis Rate
Measured: up to 12 months
Secondary outcomes (5)
Alpha Fetoprotein Response (AFP-R)
AFP-R is defined as a >20% decrease in AFP serum level from baseline to the time of liver transplant, if liver transplant is not possible, the final AFP level would be measured as the AFP level at 12 months.
Measured: up to 12 months
Progression-free survival (PFS)
PFS is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by independent radiologic review according to mRECIST criteria or death from any cause.
Measured: up to 12 months
Objective Response Rate (ORR)
RR is defined as the proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response(CR) and partial response(PR) by independent radiologic review according to mRECIST criteria.
Measured: up to 12 months
Time to Progression (TTP)
TTP is defined as the duration from the date of patient recruited to the first progress at any site or the date of death from any cause.
Measured: up to 12 months
Duration of response (DOR)
DOR is defined as the duration from the date that measurement criteria are met for CR or PR to the first progress at any site or the date of death from any cause.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start20 May 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xia, MD, Ph.D, Study chair, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTUYong-rui Bai, MD, Study chair, Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTUXiu-mei Ma, MD, Principal investigator, Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTUXiao-hang Wang, MD, Principal investigator, Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTUHao Feng, MD, Ph.D, Principal investigator, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339581
- Sponsor's protocol ID
- Renji-IIT2022-011
- Acronym
- iPLENTY-pvtt
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT Study on the Safety and Efficacy of IMRT Combined With PD-1 Blockade and LEnvatinib as Neoadjuvant TherapY for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (Vp3) Before Liver Transplantation（iPLENTY-pvtt）
- ClinicalTrials.gov ID
- NCT05339581
- Acronym / sponsor ID
- iPLENTY-pvtt / Renji-IIT2022-011
- Conditions
- Liver Cancer, Liver Transplant; Complications, Hepatocellular Carcinoma, Portal Vein Thrombosis, Radiotherapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 21 Apr 2022 (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 is a parallel assigned, open-label, perspective trial studying the safety and efficacy of intensity-modulated radiotherapy (IMRT) combined with PD-1 Blockade and Lenvatinib for Hepatocellular Carcinoma (HCC) with Vp3 Portal Vein Tumor Thrombus (PVTT, Japanese Liver Cancer Study Group classification) before liver transplantation.
Detailed description
In most criteria (e.g.Milan, UCSF, Up-to-seven), PVTT remains as an absolute contraindication for liver transplant due to the high rate of recurrence and poor prognosis. Neoadjuvant therapy has induced pathological responses in multiple tumor types and might decrease the risk of postoperative recurrence in HCC. The primary endpoint is the necrosis rate of PVTT and the primary tumor.
Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a regular treatment cycle and Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily. Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT combined with PD-1 Blockade and Lenvatinib | Experimental | Radiation: intensity-modulated radiotherapy, Combination Product: Pembrolizumab, Drug: Sintilimab, Drug: Camrelizumab, Drug: Tislelizumab, Drug: Lenvatinib Mesylate CapsuleParticipants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a 21-day treatment cycle until >42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until >7 days before liver transplantation. Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk. |
| PD-1 Blockade and Lenvatinib | Active comparator | Combination Product: Pembrolizumab, Drug: Sintilimab, Drug: Camrelizumab, Drug: Tislelizumab, Drug: Lenvatinib Mesylate CapsuleParticipants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a 21-day treatment cycle until >42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until >7 days before liver transplantation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma（exceeding Milan criteria）; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed.
- The maximum diameter of a single tumor ≤9cm. Or the number of tumors ≤3 and the maximum diameter of the largest tumors ≤5cm, and the sum of the maximum diameters of all tumors ≤9cm.
- Vp3 PVTT according to Japanese Vp classification.
- Without lymph node metastasis or extrahepatic metastasis.
- Baseline AFP≥20ng/ mL
Key exclusion criteria (21 listed)
- • Known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant.
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 |
|---|---|---|
| intensity-modulated radiotherapyAlso: IMRTNeoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk. | Radiation | IMRT combined with PD-1 Blockade and Lenvatinib |
| PembrolizumabAlso: KeytrudaParticipants receive PD-1 Blockade (Pembrolizumab 200mg，Sintilimab 200mg， Camrelizumab 200mg，Tislelizumab 200mg) 100-200 mg intravenously on day 1 of a regular treatment cycle until >42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until >7 days before liver transplantation. | Combination product | IMRT combined with PD-1 Blockade and Lenvatinib, PD-1 Blockade and Lenvatinib |
| SintilimabAlso: TyvytSintilimab is a recombinant anti-human PD-1 monoclonal antibody. | Drug | IMRT combined with PD-1 Blockade and Lenvatinib, PD-1 Blockade and Lenvatinib |
| CamrelizumabAlso: AiRuiKaCamrelizumab is a humanized anti-human PD-1 monoclonal antibody. | Drug | IMRT combined with PD-1 Blockade and Lenvatinib, PD-1 Blockade and Lenvatinib |
| TislelizumabTislelizumab is a recombinant anti-human PD-1 monoclonal antibody. | Drug | IMRT combined with PD-1 Blockade and Lenvatinib, PD-1 Blockade and Lenvatinib |
| Lenvatinib Mesylate CapsuleAlso: LENVIMALenvatinib (Lenvima®, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT. | Drug | IMRT combined with PD-1 Blockade and Lenvatinib, PD-1 Blockade and Lenvatinib |
Primary outcome
PVTT RR/NR
Time frame: up to 12 months
Portal vein tumor thrombus related Response and Necrosis Rate
5 secondary outcomes
Alpha Fetoprotein Response (AFP-R)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 12 months
Objective Response Rate (ORR)
Time frame: up to 12 months
Time to Progression (TTP)
Time frame: up to 12 months
Duration of response (DOR)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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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.
Qiang Xia, MD, Ph.D contact
Qiang Xia, MD, Ph.D study chair
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
Yong-rui Bai, MD study chair
Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU
Xiu-mei Ma, MD principal investigator
Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensity-modulated radiotherapy, Pembrolizumab and Sintilimab in people with Liver Cancer and Liver Transplant; Complications, run by RenJi 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 22 inclusion and 21 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 27 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Feng, MD, Ph.D (008615000901110, surgeonfeng@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVTT RR/NR (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.