OsteosarcomaPhase 1/2IACE-OSNCT06562673
Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma
A Phase 1/2 study testing intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) in people with Osteosarcoma and Bone Cancer, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Osteosarcoma, Bone Cancer
- What is being tested?
- intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 20 Jul 2025
- Phase
- Phase 1/2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of osteosarcoma patients aged 12-40 years old;
- Accept to receive treatment with neoadjuvant chemotherapy regimen and completing the standard treatment course; Voluntary informed consent, joining the study with good compliance.
- Have detailed medical data (such as medical history data, laboratory reports of blood routine and liver and kidney functions, pathology reports, etc.), and complete records of postoperative follow-up.
Who cannot join
- Combined history of acute injury, infection and surgery in the last 3 months;
- Those with severe liver and kidney function abnormalities;
- Those who are using anti-inflammatory drugs;
- Pre-existing hematologic diseases before treatment;
- Combined with other malignant tumors;
- Diagnosed with autoimmune disease or using steroid drugs for more than 1 month before treatment;
- Suffering from mental illness or cognitive dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital,
Shanghai, 200233
About this study
Official title: Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma
The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. The main questions it aims to answer are:
- Is it safe when rh-endostatin and cisplatin are administered intra-arterially?
- Does intra-arterial cisplatin plus rh-endostatin increase the rate of tumor necrosis compared with traditional treatment?
Read more
Researchers will treat newly diagnosed osteosarcoma patients with systematic treatment and local treatment.
For systematic treatment, regular high-dose methotrexate and adriamycin will be administered intravenously.
For local treatment, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion.
Local treatment is conducted by insertion of a catheter percutaneously using the Seldinger technique through the brachial or femoral artery under local anesthesia.
Participants will:
- Receive local combined with systematic treatment once every 2-3 weeks for 2-4 cycles before surgery.
Read the detailed description
Osteosarcoma (OS) is the most common bone cancer in children and young adolescents. Despite the emergence of new therapeutic modalities such as targeted therapy and immunotherapy, chemotherapy remains the standard treatment. The current standard treatment for osteosarcoma is the preoperative chemotherapy, surgery and postoperative chemotherapy. Preoperative chemotherapy (or neoadjuvant chemotherapy) and neoadjuvant chemotherapeutic agents include cisplatin, adriamycin, methotrexate. The use of preoperative chemotherapy has increased the 5-year survival rate from 20% to 60%-70%. Over the past 40 years, limited progress has been made in improving survival outcomes in patients with OS.
Transcatheter arterial infusion (TAI) is the direct infusion of drugs in the tumor blood supply artery, which can overcome the physiological barrier that some intravenous drug can not pass, thus significantly increasing the local drug concentration in the tumor and improving the therapeutic efficacy. Studies have shown that the combination of intravenous doxorubicin and intra-arterial cisplatin infusion before surgery resulted in a favorable histological response in 87% of enrolled patients, with a 10-year survival rate of 93% and an event-free survival rate of 86%.
Recombinant endostatin, an anti-angiogenic drug approved by the National Medical Products Administration of China in 2005 for the treatment of non-small cell lung cancer. In preclinical studies, synergistic antitumor efficacy was observed in an osteosarcoma mouse model with the addition of rh-endostatin to doxorubicin. In the clinical study of osteosarcoma, after comparing 58 patients with stage IIB osteosarcoma treated with chemotherapy combined with endostatin and 272 patients treated with chemotherapy alone, results show that the 5-year DMFS (distant metastasis-free survival) of the control group (61%) was significantly lower than that of the rh-endostatin group (79%) (P = 0.013). The 5-year OS of the control group (74%) was significantly lower than that of the rh-endostatin treatment group (87%) (P = 0.029). These results suggest that endostatin combined with chemotherapy for osteosarcoma significantly improves distant metastasis-free survival, with tolerable adverse effects, and is worthy of further clinical investigation.
Therefore, the investigators propose that arterial infusion of endostatin and cisplatin combined with systematic therapy might improve the treatment efficacy in preoperative course.
- Conditions
- Osteosarcoma, Bone Cancer
- Being tested
- intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)
- Keywords
- osteosarcoma, intra-arterial, anti-angiogenesis inhibitor, endostatin, cisplatin
- Medical subject headings
- Osteosarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)Drug
Also called intra-arterial treatment
After insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under local anesthesia, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| IA cisplatin plus endostatin | Experimental | Intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy Receives: Drug: intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Safety analysis (adverse events) according to CTCAE 5.0
Measured: From enrollment to the end of treatment at 1-month
Incidence of tumor response
according to tumor cell necrosis rate (TCNR) of tumor tissue sample after surgery.
Measured: From enrollment to the end of treatment at 1 month
Secondary outcomes (1)
Microvessel density
the measurement of microvessel density (MVD) detected in tumor tissue sample after surgery.
Measured: From enrollment to the end of treatment at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start3 Dec 2024
- Primary completion17 Apr 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong-Tao Li, Shanghai 6th People's Hospital
- Investigators
- Hong-Tao Li, Dr., Principal investigator, Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562673
- Sponsor's protocol ID
- 2024-098-(1)
- Other IDs
- 2024-098-(1)
- Acronym
- IACE-OS
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only IPD used in the results publication
Publications
Xu H, Huang Z, Li Y, Zhang Q, Hao L, Niu X. Perioperative rh-endostatin with chemotherapy improves the survival of conventional osteosarcoma patients: a prospective non-randomized controlled study. Cancer Biol Med. 2019 Feb;16(1):166-172. doi: 10.20892/j.issn.2095-3941.2018.0315.
PubMed 31119057Shaikh R, Munoz FG. Endovascular approaches in pediatric interventional oncology. CVIR Endovasc. 2021 Jan 2;4(1):2. doi: 10.1186/s42155-020-00190-7.
PubMed 33387076Xie L, Xu J, Dong S, Gao J, Tang X, Yan T, Yang R, Guo W. Gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma: a retrospective study of 99 cases in the past six years. Cancer Manag Res. 2019 Jul 30;11:7183-7195. doi: 10.2147/CMAR.S214604. eCollection 2019.
PubMed 31447583Avritscher R, Javadi S. Transcatheter intra-arterial limb infusion for extremity osteosarcoma: technical considerations and outcomes. Tech Vasc Interv Radiol. 2011 Sep;14(3):124-8. doi: 10.1053/j.tvir.2011.02.004.
PubMed 21767779Zhang HJ, Yang JJ, Lu JP, Lai CJ, Sheng J, Li YX, Hao Q, Zhang SM, Gupta S. Use of intra-arterial chemotherapy and embolization before limb salvage surgery for osteosarcoma of the lower extremity. Cardiovasc Intervent Radiol. 2009 Jul;32(4):672-8. doi: 10.1007/s00270-009-9546-2. Epub 2009 Mar 19.
PubMed 19296158Wilkins RM, Cullen JW, Camozzi AB, Jamroz BA, Odom L. Improved survival in primary nonmetastatic pediatric osteosarcoma of the extremity. Clin Orthop Relat Res. 2005 Sep;438:128-36. doi: 10.1097/01.blo.0000179736.10871.76.
PubMed 16131881Wilkins RM, Cullen JW, Odom L, Jamroz BA, Cullen PM, Fink K, Peck SD, Stevens SL, Kelly CM, Camozzi AB. Superior survival in treatment of primary nonmetastatic pediatric osteosarcoma of the extremity. Ann Surg Oncol. 2003 Jun;10(5):498-507. doi: 10.1245/aso.2003.03.061.
PubMed 12794015Rao BN, Rodriguez-Galindo C. Intra-arterial cisplatin in osteosarcoma: same question, different answer. Ann Surg Oncol. 2003 Jun;10(5):481-3. doi: 10.1245/aso.2003.04.903. No abstract available.
PubMed 12794009Wanebo HJ, Temple WJ, Popp MB, Constable W, Aron B, Cunningham SL. Preoperative regional therapy for extremity sarcoma. A tricenter update. Cancer. 1995 May 1;75(9):2299-306. doi: 10.1002/1097-0142(19950501)75:93.0.co;2-y.
PubMed 7712441Bielack SS, Bieling P, Erttmann R, Winkler K. Intraarterial chemotherapy for osteosarcoma: does the result really justify the effort? Cancer Treat Res. 1993;62:85-92. doi: 10.1007/978-1-4615-3518-8_12.
PubMed 8096763
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma
- ClinicalTrials.gov ID
- NCT06562673
- Acronym / sponsor ID
- IACE-OS / 2024-098-(1)
- Conditions
- Osteosarcoma, Bone Cancer
- Keywords
- osteosarcoma, intra-arterial, anti-angiogenesis inhibitor, endostatin, cisplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. The main questions it aims to answer are:
- Is it safe when rh-endostatin and cisplatin are administered intra-arterially?
- Does intra-arterial cisplatin plus rh-endostatin increase the rate of tumor necrosis compared with traditional treatment?
Researchers will treat newly diagnosed osteosarcoma patients with systematic treatment and local treatment.
For systematic treatment, regular high-dose methotrexate and adriamycin will be administered intravenously.
For local treatment, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion.
Local treatment is conducted by insertion of a catheter percutaneously using the Seldinger technique through the brachial or femoral artery under local anesthesia.
Participants will:
- Receive local combined with systematic treatment once every 2-3 weeks for 2-4 cycles before surgery.
Detailed description
Osteosarcoma (OS) is the most common bone cancer in children and young adolescents. Despite the emergence of new therapeutic modalities such as targeted therapy and immunotherapy, chemotherapy remains the standard treatment. The current standard treatment for osteosarcoma is the preoperative chemotherapy, surgery and postoperative chemotherapy. Preoperative chemotherapy (or neoadjuvant chemotherapy) and neoadjuvant chemotherapeutic agents include cisplatin, adriamycin, methotrexate. The use of preoperative chemotherapy has increased the 5-year survival rate from 20% to 60%-70%. Over the past 40 years, limited progress has been made in improving survival outcomes in patients with OS.
Transcatheter arterial infusion (TAI) is the direct infusion of drugs in the tumor blood supply artery, which can overcome the physiological barrier that some intravenous drug can not pass, thus significantly increasing the local drug concentration in the tumor and improving the therapeutic efficacy. Studies have shown that the combination of intravenous doxorubicin and intra-arterial cisplatin infusion before surgery resulted in a favorable histological response in 87% of enrolled patients, with a 10-year survival rate of 93% and an event-free survival rate of 86%.
Recombinant endostatin, an anti-angiogenic drug approved by the National Medical Products Administration of China in 2005 for the treatment of non-small cell lung cancer. In preclinical studies, synergistic antitumor efficacy was observed in an osteosarcoma mouse model with the addition of rh-endostatin to doxorubicin. In the clinical study of osteosarcoma, after comparing 58 patients with stage IIB osteosarcoma treated with chemotherapy combined with endostatin and 272 patients treated with chemotherapy alone, results show that the 5-year DMFS (distant metastasis-free survival) of the control group (61%) was significantly lower than that of the rh-endostatin group (79%) (P = 0.013). The 5-year OS of the control group (74%) was significantly lower than that of the rh-endostatin treatment group (87%) (P = 0.029). These results suggest that endostatin combined with chemotherapy for osteosarcoma significantly improves distant metastasis-free survival, with tolerable adverse effects, and is worthy of further clinical investigation.
Therefore, the investigators propose that arterial infusion of endostatin and cisplatin combined with systematic therapy might improve the treatment efficacy in preoperative course.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IA cisplatin plus endostatin | Experimental | Drug: intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)Intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of osteosarcoma patients aged 12-40 years old;
- Accept to receive treatment with neoadjuvant chemotherapy regimen and completing the standard treatment course; Voluntary informed consent, joining the study with good compliance.
- Have detailed medical data (such as medical history data, laboratory reports of blood routine and liver and kidney functions, pathology reports, etc.), and complete records of postoperative follow-up.
Key exclusion criteria (7 listed)
- Combined history of acute injury, infection and surgery in the last 3 months;
- Those with severe liver and kidney function abnormalities;
- Those who are using anti-inflammatory drugs;
- Pre-existing hematologic diseases before treatment;
- Combined with other malignant tumors;
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 |
|---|---|---|
| intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)Also: intra-arterial treatmentAfter insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under local anesthesia, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion. | Drug | IA cisplatin plus endostatin |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to the end of treatment at 1-month
Safety analysis (adverse events) according to CTCAE 5.0
Incidence of tumor response
Time frame: From enrollment to the end of treatment at 1 month
according to tumor cell necrosis rate (TCNR) of tumor tissue sample after surgery.
1 secondary outcome
Microvessel density
Time frame: From enrollment to the end of treatment at 1 month
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 29 Dec 2025.
- Background: PubMed 31119057Xu H, Huang Z, Li Y, Zhang Q, Hao L, Niu X. Perioperative rh-endostatin with chemotherapy improves the survival of conventional osteosarcoma patients: a prospective non-randomized controlled study. Cancer Biol Med. 2019 Feb;16(1):166-172. doi: 10.20892/j.issn.2095-3941.2018.0315.
- Background: PubMed 33387076Shaikh R, Munoz FG. Endovascular approaches in pediatric interventional oncology. CVIR Endovasc. 2021 Jan 2;4(1):2. doi: 10.1186/s42155-020-00190-7.
- Background: PubMed 31447583Xie L, Xu J, Dong S, Gao J, Tang X, Yan T, Yang R, Guo W. Gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma: a retrospective study of 99 cases in the past six years. Cancer Manag Res. 2019 Jul 30;11:7183-7195. doi: 10.2147/CMAR.S214604. eCollection 2019.
- Background: PubMed 21767779Avritscher R, Javadi S. Transcatheter intra-arterial limb infusion for extremity osteosarcoma: technical considerations and outcomes. Tech Vasc Interv Radiol. 2011 Sep;14(3):124-8. doi: 10.1053/j.tvir.2011.02.004.
- Background: PubMed 19296158Zhang HJ, Yang JJ, Lu JP, Lai CJ, Sheng J, Li YX, Hao Q, Zhang SM, Gupta S. Use of intra-arterial chemotherapy and embolization before limb salvage surgery for osteosarcoma of the lower extremity. Cardiovasc Intervent Radiol. 2009 Jul;32(4):672-8. doi: 10.1007/s00270-009-9546-2. Epub 2009 Mar 19.
- Background: PubMed 16131881Wilkins RM, Cullen JW, Camozzi AB, Jamroz BA, Odom L. Improved survival in primary nonmetastatic pediatric osteosarcoma of the extremity. Clin Orthop Relat Res. 2005 Sep;438:128-36. doi: 10.1097/01.blo.0000179736.10871.76.
- Background: PubMed 12794015Wilkins RM, Cullen JW, Odom L, Jamroz BA, Cullen PM, Fink K, Peck SD, Stevens SL, Kelly CM, Camozzi AB. Superior survival in treatment of primary nonmetastatic pediatric osteosarcoma of the extremity. Ann Surg Oncol. 2003 Jun;10(5):498-507. doi: 10.1245/aso.2003.03.061.
- Background: PubMed 12794009Rao BN, Rodriguez-Galindo C. Intra-arterial cisplatin in osteosarcoma: same question, different answer. Ann Surg Oncol. 2003 Jun;10(5):481-3. doi: 10.1245/aso.2003.04.903. No abstract available.
- Background: PubMed 7712441Wanebo HJ, Temple WJ, Popp MB, Constable W, Aron B, Cunningham SL. Preoperative regional therapy for extremity sarcoma. A tricenter update. Cancer. 1995 May 1;75(9):2299-306. doi: 10.1002/1097-0142(19950501)75:93.0.co;2-y.
- Background: PubMed 8096763Bielack SS, Bieling P, Erttmann R, Winkler K. Intraarterial chemotherapy for osteosarcoma: does the result really justify the effort? Cancer Treat Res. 1993;62:85-92. doi: 10.1007/978-1-4615-3518-8_12.
- Individual participant dataSharing planned: Undecided. only IPD used in the results publication
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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.
Hong-Tao Li, Dr. principal investigator
Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) in people with Osteosarcoma and Bone Cancer, run by Shanghai 6th People's 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 3 inclusion and 7 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 29 Dec 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: From enrollment to the end of treatment at 1-month). The study lists 2 primary outcomes in all. 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 NCT06562673, which also lists 10 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 29 Dec 2025.