OsteosarcomaPhase 2PROMISNCT06114225
Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical Trial
A Phase 2 study testing metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy in people with Osteosarcoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical metastasectomy for resectable metastatic osteosarcoma. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2026
- Phase
- Phase 2
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent signed before any trial-related procedures are carried out.
- Histologically confirmed osteosarcoma, with a diagnosis of pulmonary metastases without the existence of local recurrence (previous re-resection of local recurrence with wide margin is allowed).
- Resectable pulmonary nodule(s), defined as nodule(s) that are removable by wedge resection/ segmentectomy/lobectomy without necessitating a total pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels), and no evidences of malignant pleural effusion.
- Participants have received at least one standardized systemic treatment regimen at the time of enrollment, and have not received gemcitabine in the past.
- Patient has adequate pulmonary function eligible for one-staged or two-staged thoracic surgery.
- Aged no less than 10 years old and no more than 65 years old;
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- For patients ≥16 years old, ECOG score is between 0 and 2 (for patients with amputations, if they can basically take care of themselves and can move freely for more than 50% of their waking hours with the assistance of stretchers, walkers, wheelchairs, etc.) still included);
- For patients under 16 years old, Lansky score is at least 70 or above (for patients with amputations who are unable to participate in active recreational activities due to amputation, if they can participate in most active recreational activities with the assistance of walkers, wheelchairs, etc., they are still eligible included).
- The expected survival time is greater than 24 weeks;
- The majority of the recurrent lesions with an established radiological diagnosis could receive SBRT;
- Major organ functions meet basic safety standards within 7-14 days before treatment.
- Women of childbearing age should agree that they must use contraceptive measures (such as intrauterine devices, birth control pills or condoms) during the study and within 6 months after the end of the study; if in doubt, serum or urine tests within 7 days before study enrollment The pregnancy test is negative and the patient must be non-lactating; the male should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period;
- If there are recurrent lesions previously treated by surgery, radiofrequency ablation or radiotherapy:
- If the image of the metastatic lesion is stable, enrollment is allowed and SBRT is not required for that lesion;
- If the metastatic lesion has image progression, if it was previously treated with surgery and SBRT can be performed, enrollment is allowed; if it was previously treated with radiofrequency ablation or radiotherapy, if repeat SBRT can be considered, enrollment is still allowed.
Who cannot join
- Diagnosed with malignant diseases other than tumors within 5 years before the first dose;
- Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) drug and secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment).
- Received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except local use to control pleural effusion) within 2 weeks before the first dose;
- Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
- Are receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled or other route of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study;
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- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known to be allergic to any components of monoclonal antibody preparations (have experienced grade 3 or above allergic reactions);
- Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1/2 antibody positive);
- Get live vaccine within 30 days before the first dose (cycle 1, day 1);
- Pregnant or lactating women;
- Any serious or uncontrollable systemic disease
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, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 20025
Qiyuan Bao, MD., Ph.D, +86 13818971504, rblw_110@hotmail.com
About this study
Official title: A Prospective Phase II Clinical Trial on Pre-operative Immunotherapy and Stereotactic Body Radiotherapy Followed by Metastasectomy in Patients With Pulmonary Resectable Recurrence of Osteosarcoma
The aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical metastasectomy for resectable metastatic osteosarcoma.
Read the detailed description
Osteosarcoma is a primary bone malignant tumor with strong metastatic potential. About 15%-20% of osteosarcomas are accompanied by lung metastasis when diagnosed, and about 40% of patients develop secondary lung metastasis after radical surgery of the primary lesion. However, pulmonary metastatic osteosarcoma are often insensitive to traditional radiotherapy and chemotherapy. For resectable lung metastases, the preferred treatment is still complete resection of all metastases and the best therapeutic modality and regimens pre- and post-surgical remains unestablished.
With the advent of immunotherapy, many common solid tumors have made substantial progress through immunotherapy after distant metastasis. However, a number of current clinical studies on immunotherapy for osteosarcoma have shown that the effective rate of immunotherapy for osteosarcoma is about 5% to 10% after single agent treatment, making it regarded as one of the "immune cold" tumor, potentially due to the fact that osteosarcoma often lacks immune cell infiltration, and immune cells in tumors are often difficult to be activated or preserve immune memory. However, the investigators have found in our previous clinical observations that a small number of osteosarcoma patients not only have significant effects on immunotherapy, but even have long-term responses. The investigators unexpectedly found that the degree of tumor pro-inflammatory factors and lymphocyte infiltration in the osteosarcoma sample significantly increased after radiotherapy, especially SBRT. The investigators also discovered that the induction of the formation of "tertiary lymphatic structure" within the tumor might be possible through SBRT as a potential sensitization strategy for immunotherapy in osteosarcoma, which is consistent with the recent knowledge of rado-immunotherapy of several solid tumors.
Therefore, the investigators aim to conduct a prospective phase II clinical trial on pre-operative immunotherapy and stereotactic body radiotherapy (SBRT), followed by metastasectomy in patients with pulmonary resectable recurrence of osteosarcoma. To explore the potential mechanisms related to the pre-operative sensitization of immunotherapy, correlative biomarker analysis is to be performed to explore the tumor microenvironment pre- and post- SBRT to pave the way for further precision immunotherapy of bone sarcoma in the future.
- Conditions
- Osteosarcoma
- Being tested
- metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy
- Keywords
- neoadjuvant immunotherapy, metastasectomy, osteosarcoma, pulmonary metastasis
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapyCombination product
participants first receive concurrent SBRT and penpulimab (PD-1 blockade) and two cycles of GP regimen (gemcitabine d1,d8 and Penpulimab d8 per a 21-day cycle), followed by complete pulmonary metastasectomy. After surgery, participant receive another 4 cycles of GP regimens followed by Penpulimab monotherapy maintenance. The rationale is that pre-operative SBRT could boost the immune microenvironment, leading to a long-term effect of immunotherapy post-metastasectomy and eventually resulting in better long-term survivorship compared to the histological control for pulmonary resectable recurrence of osteosarcoma .
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | The participant receive metastasectomy, immunotherapy and Stereotactic Body Radiotherapy (SBRT) Receives: Combination Product: metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month progression-free survival rate (12m-PFSR)
The proportion of patients that are progression-free according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), defined as the ratio of patients who have not died or progressed (CR+PR+SD) over the total number of subjects recruited.
Measured: 12 months from recruitment
Secondary outcomes (8)
Objective response rate (ORR)
Defined as the number of subjects with a best response of (CR+PR)/total number of subjects*100% based on RECISTv1.1 and irRECIST standards respectively
Measured: From baseline to disease progression, death or the time of metastasectomy, whichever occurs first, up to 3 years after accrual
Disease control rate (DCR)
Defined as the number of subjects with a best response of (CR+PR+SD)/total number of subjects*100% based on RECISTv1.1 and irRECIST standards respectively;
Measured: From baseline to disease progression, death or the time of metastasectomy, whichever occurs first, up to 3 years after accrual
Progression-free survival (PFS)
Defined as the time from receiving the first study drug to the death or relapse of the subject, assessed by RECISTv1.1 and irRECIST standards respectively, and estimated by the Kaplan-Meier method, including median, quartile and 95% confidence interval
Measured: From baseline to disease progression or death, whichever occurs first, up to 3 years after accrual
Overall survival (OS)
defined as the time from receiving the first study drug treatment to the subject's death, estimated by the Kaplan-Meier method, including median, quartile and 95% confidence interval;
Measured: From baseline until the reported death of the patients due to any causes, up to 3 years after accrual
Quality of life assessed by patient-reported outcomes (PROs)
Assessement of the quality of life score using PROs based on EORTC QLQ-C30 scale (adult) or Paediatric Quality of Life Inventory (PedsQL) scale at baseline and at each followed up after treatment.
Measured: From baseline until the reported death of the patients due to any causes, up to 3 years after accrual
Number of participants with adverse events
Number of participants with Treatment emergent adverse events (TEAE) and serious adverse events (SAE). AE was defines as any toxicities in a participant who received study therapy irrespective of the causal relationship. SAE was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity or inpatient hospitalization or prolongation of existing hospitalization.
Measured: From the first dose of study treatment to 30 days after the last dose of study treatment or before the start day of new anti-cancer drug therapy, whichever occurs first, up to 3 years.
The rate of tumor resectability
Tumor resectability is defined as the number of patients undergoing pre-planned metastasectomy divided by the number of patients considered resectable at baseline.
Measured: At the time of metastasectomy, an average of 8~9 weeks
The incidence of peri-operative complications
Peri-operative complications is defined as the incidence of complications during and following metastasectomy surgery
Measured: At the time of metastasectomy, an average of 8~9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jun 2023
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibin Zhang, MD, PhD., Ruijin Hospital
- Investigators
- Weibin Zhang, PhD, MD, Principal investigator, Ruijin HospitalYuhui Shen, PhD, MD, Principal investigator, Ruijin HospitalQiyuan Bao, PhD, MD, Principal investigator, Ruijin HospitalJunxiang Wen, PhD, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114225
- Sponsor's protocol ID
- 2023-LLS-221
- Acronym
- PROMIS
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data (IPD) will be available to academic research upon reasonable request, under the local official rules and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Trial on Pre-operative Immunotherapy and Stereotactic Body Radiotherapy Followed by Metastasectomy in Patients With Pulmonary Resectable Recurrence of Osteosarcoma
- ClinicalTrials.gov ID
- NCT06114225
- Acronym / sponsor ID
- PROMIS / 2023-LLS-221
- Conditions
- Osteosarcoma
- Keywords
- neoadjuvant immunotherapy, metastasectomy, osteosarcoma, pulmonary metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Nov 2023 (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 aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical metastasectomy for resectable metastatic osteosarcoma.
Detailed description
Osteosarcoma is a primary bone malignant tumor with strong metastatic potential. About 15%-20% of osteosarcomas are accompanied by lung metastasis when diagnosed, and about 40% of patients develop secondary lung metastasis after radical surgery of the primary lesion. However, pulmonary metastatic osteosarcoma are often insensitive to traditional radiotherapy and chemotherapy. For resectable lung metastases, the preferred treatment is still complete resection of all metastases and the best therapeutic modality and regimens pre- and post-surgical remains unestablished.
With the advent of immunotherapy, many common solid tumors have made substantial progress through immunotherapy after distant metastasis. However, a number of current clinical studies on immunotherapy for osteosarcoma have shown that the effective rate of immunotherapy for osteosarcoma is about 5% to 10% after single agent treatment, making it regarded as one of the "immune cold" tumor, potentially due to the fact that osteosarcoma often lacks immune cell infiltration, and immune cells in tumors are often difficult to be activated or preserve immune memory. However, the investigators have found in our previous clinical observations that a small number of osteosarcoma patients not only have significant effects on immunotherapy, but even have long-term responses. The investigators unexpectedly found that the degree of tumor pro-inflammatory factors and lymphocyte infiltration in the osteosarcoma sample significantly increased after radiotherapy, especially SBRT. The investigators also discovered that the induction of the formation of "tertiary lymphatic structure" within the tumor might be possible through SBRT as a potential sensitization strategy for immunotherapy in osteosarcoma, which is consistent with the recent knowledge of rado-immunotherapy of several solid tumors.
Therefore, the investigators aim to conduct a prospective phase II clinical trial on pre-operative immunotherapy and stereotactic body radiotherapy (SBRT), followed by metastasectomy in patients with pulmonary resectable recurrence of osteosarcoma. To explore the potential mechanisms related to the pre-operative sensitization of immunotherapy, correlative biomarker analysis is to be performed to explore the tumor microenvironment pre- and post- SBRT to pave the way for further precision immunotherapy of bone sarcoma in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Combination Product: metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapyThe participant receive metastasectomy, immunotherapy and Stereotactic Body Radiotherapy (SBRT) |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent signed before any trial-related procedures are carried out.
- Histologically confirmed osteosarcoma, with a diagnosis of pulmonary metastases without the existence of local recurrence (previous re-resection of local recurrence with wide margin is allowed).
- Resectable pulmonary nodule(s), defined as nodule(s) that are removable by wedge resection/ segmentectomy/lobectomy without necessitating a total pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels), and no evidences of malignant pleural effusion.
- Participants have received at least one standardized systemic treatment regimen at the time of enrollment, and have not received gemcitabine in the past.
- Patient has adequate pulmonary function eligible for one-staged or two-staged thoracic surgery.
Key exclusion criteria (13 listed)
- Diagnosed with malignant diseases other than tumors within 5 years before the first dose;
- Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) drug and secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment).
- Received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except local use to control pleural effusion) within 2 weeks before the first dose;
- Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
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 |
|---|---|---|
| metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapyparticipants first receive concurrent SBRT and penpulimab (PD-1 blockade) and two cycles of GP regimen (gemcitabine d1,d8 and Penpulimab d8 per a 21-day cycle), followed by complete pulmonary metastasectomy. After surgery, participant receive another 4 cycles of GP regimens followed by Penpulimab monotherapy maintenance. The rationale is that pre-operative SBRT could boost the immune microenvironment, leading to a long-term effect of immunotherapy post-metastasectomy and eventually resulting in better long-term survivorship compared to the histological control for pulmonary resectable recurrence of osteosarcoma . | Combination product | treatment arm |
Primary outcome
12-month progression-free survival rate (12m-PFSR)
Time frame: 12 months from recruitment
The proportion of patients that are progression-free according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), defined as the ratio of patients who have not died or progressed (CR+PR+SD) over the total number of subjects recruited.
8 secondary outcomes
Objective response rate (ORR)
Time frame: From baseline to disease progression, death or the time of metastasectomy, whichever occurs first, up to 3 years after accrual
Disease control rate (DCR)
Time frame: From baseline to disease progression, death or the time of metastasectomy, whichever occurs first, up to 3 years after accrual
Progression-free survival (PFS)
Time frame: From baseline to disease progression or death, whichever occurs first, up to 3 years after accrual
Overall survival (OS)
Time frame: From baseline until the reported death of the patients due to any causes, up to 3 years after accrual
Quality of life assessed by patient-reported outcomes (PROs)
Time frame: From baseline until the reported death of the patients due to any causes, up to 3 years after accrual
Number of participants with adverse events
Time frame: From the first dose of study treatment to 30 days after the last dose of study treatment or before the start day of new anti-cancer drug therapy, whichever occurs first, up to 3 years.
The rate of tumor resectability
Time frame: At the time of metastasectomy, an average of 8~9 weeks
The incidence of peri-operative complications
Time frame: At the time of metastasectomy, an average of 8~9 weeks
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 2 Nov 2023.
- Individual participant dataSharing planned: Undecided. individual participant data (IPD) will be available to academic research upon reasonable request, under the local official rules and regulations.
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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.
Weibin Zhang, PhD, MD principal investigator
Ruijin Hospital
Yuhui Shen, PhD, MD principal investigator
Ruijin Hospital
Qiyuan Bao, PhD, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy in people with Osteosarcoma, run by Ruijin 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 15 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 Weibin Zhang, PhD, MD (+8613501824630, zhangweibin10368@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month progression-free survival rate (12m-PFSR) (time frame: 12 months from recruitment). 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 2 Nov 2023.