Osteosarcoma MetastaticNCT06927596
A Look Back at How Well Interventional Treatments Work for Bronchopleural Fistulas in Patients With Lung Metastases From Osteosarcoma
An observational study of Osteosarcoma Metastatic, run by Ruijin Hospital.
Trial summary
Patients with pulmonary metastasis of osteosarcoma complicated with BPF often suffer from massive hemoptysis, refractory pneumothorax and difficult fistula healing due to tumor erosion of bronchial arteries. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Osteosarcoma Metastatic
- What is being tested?
- Interventional therapy
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Observational
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From January 1, 2019 to December 31, 2023, patients with pulmonary metastasis of osteosarcoma complicated with BPLF who underwent interventional treatment in the hospital were enrolled.
Who may be able to join
- The patient was diagnosed with osteosarcoma by histology or cytology, and pulmonary metastasis with bronchopleural fistula (BPF) was confirmed by imaging (CT/PET-CT);
- Present with clinical symptoms associated with BPF (e.g., hemoptysis, pneumothorax, persistent pleural infection, etc.) that are ineffective or poorly responded to traditional treatments (pharmacologic hemostasis, closed thoracic drainage);
- Angiographically confirmed abnormal bronchial or intercostal artery blood supply to the fistula and anatomy suitable for NBCA with coil embolization;
- Age ≤75 years, ECOG performance status ≤2, and predicted survival ≥3 months.
- Coagulation function was basically normal.
Who cannot join
- Had a history of severe allergy or contraindication to NBCA glue, iodine contrast agent or coil materials;
- Severe cardiopulmonary dysfunction (e.g., NYHA class III-IV, FEV1 < 30% predicted, uncontrolled pulmonary hypertension);
- Angiographic abnormalities of the target vessel anatomy (e.g., severe tortuosity, stenosis, or occlusion) prevented the catheter from safely reaching the target embolization site;
- Active systemic infection (e.g., sepsis, active tuberculosis) or uncontrolled local infection;
- Other major organ failure (Child-Pugh C cirrhosis, eGFR < 30 mL/min/1.73m²);
- Women who are pregnant or lactating or plan to become pregnant during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective Study on the Efficacy of Interventional Treatment for Bronchopleural Fistula Related to Pulmonary Metastasis of Osteosarcoma
Patients with pulmonary metastasis of osteosarcoma complicated with BPF often suffer from massive hemoptysis, refractory pneumothorax and difficult fistula healing due to tumor erosion of bronchial arteries. Traditional interventional embolization (such as simple coil or gelatin sponge embolization) has some limitations such as embolic material displacement, incomplete fistula closure and postoperative recurrent bleeding. Systemic chemotherapy and radiotherapy also have poor efficacy due to the complex blood supply of local lesions and poor tissue repair ability, and the quality of life of patients is seriously impaired. Therefore, there is an urgent need to explore a safer and durable precise embolization scheme.
NBCA combined with coil closure is expected to break through the current technical bottleneck through the synergistic mechanism of "colloid embolization + mechanical occlusion". NBCA glue can quickly polymerize to achieve permanent occlusion of the micro vascular network, while the coil can strengthen the fistula through physical support. The combination of the two can not only accurately block abnormal blood supply, promote fistula healing, but also reduce the risk of embolus displacement and hemoptysis recurrence rate. This study is the first to systematically evaluate the efficacy and safety of this combination regimen in such patients, and provide key evidence for optimizing the embolization strategy and improving the long-term prognosis.
The clinical transformation value and social significance of this study are significant. If NBCA combined with coil is proved to be effective in controlling bleeding, shortening fistula closure time and reducing complications, it will promote this technology to become the first choice for advanced osteosarcoma pulmonary metastasis with complex fistula. Its minimally invasive and repeatability can help to reduce the frequency of repeated hospitalization and the risk of infection, save medical resources, and provide new ideas for the exploration of multimodal embolization techniques in interventional medicine, which has a profound impact on improving the quality of life of patients with end-stage cancer.
- Conditions
- Osteosarcoma Metastatic
- Being tested
- Interventional therapy
- Keywords
- Pulmonary metastasis of osteosarcoma, Interventional therapy, Bronchopleural fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapyProcedure or surgery
The fistula was occluded by coil and NBCA glue.
| Study group | Role | What they receive |
|---|---|---|
| Interventional THERAPY Group | Patients undergoing interventional therapy Receives: Procedure: Interventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS，Overall Survival
The patient received treatment until death.
Measured: From the time of treatment to the death from any cause, assessed up to 50 months.
PFS，Progress Free Survival
Time of progression or death of the patient.
Measured: From the time of treatment to tumor progression or date of death from any cause, whichever came first, assessed up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma MetastaticStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927596
- Sponsor's protocol ID
- 2025-173
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Efficacy of Interventional Treatment for Bronchopleural Fistula Related to Pulmonary Metastasis of Osteosarcoma
- ClinicalTrials.gov ID
- NCT06927596
- Acronym / sponsor ID
- 2025-173
- Conditions
- Osteosarcoma Metastatic
- Keywords
- Pulmonary metastasis of osteosarcoma, Interventional therapy, Bronchopleural fistula
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2025 (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.
Patients with pulmonary metastasis of osteosarcoma complicated with BPF often suffer from massive hemoptysis, refractory pneumothorax and difficult fistula healing due to tumor erosion of bronchial arteries. Traditional interventional embolization (such as simple coil or gelatin sponge embolization) has some limitations such as embolic material displacement, incomplete fistula closure and postoperative recurrent bleeding. Systemic chemotherapy and radiotherapy also have poor efficacy due to the complex blood supply of local lesions and poor tissue repair ability, and the quality of life of patients is seriously impaired. Therefore, there is an urgent need to explore a safer and durable precise embolization scheme.
NBCA combined with coil closure is expected to break through the current technical bottleneck through the synergistic mechanism of "colloid embolization + mechanical occlusion". NBCA glue can quickly polymerize to achieve permanent occlusion of the micro vascular network, while the coil can strengthen the fistula through physical support. The combination of the two can not only accurately block abnormal blood supply, promote fistula healing, but also reduce the risk of embolus displacement and hemoptysis recurrence rate. This study is the first to systematically evaluate the efficacy and safety of this combination regimen in such patients, and provide key evidence for optimizing the embolization strategy and improving the long-term prognosis.
The clinical transformation value and social significance of this study are significant. If NBCA combined with coil is proved to be effective in controlling bleeding, shortening fistula closure time and reducing complications, it will promote this technology to become the first choice for advanced osteosarcoma pulmonary metastasis with complex fistula. Its minimally invasive and repeatability can help to reduce the frequency of repeated hospitalization and the risk of infection, save medical resources, and provide new ideas for the exploration of multimodal embolization techniques in interventional medicine, which has a profound impact on improving the quality of life of patients with end-stage cancer.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional THERAPY Group | – | Procedure: Interventional therapyPatients undergoing interventional therapy |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From January 1, 2019 to December 31, 2023, patients with pulmonary metastasis of osteosarcoma complicated with BPLF who underwent interventional treatment in the hospital were enrolled.
Key inclusion criteria (5 listed)
- The patient was diagnosed with osteosarcoma by histology or cytology, and pulmonary metastasis with bronchopleural fistula (BPF) was confirmed by imaging (CT/PET-CT);
- Present with clinical symptoms associated with BPF (e.g., hemoptysis, pneumothorax, persistent pleural infection, etc.) that are ineffective or poorly responded to traditional treatments (pharmacologic hemostasis, closed thoracic drainage);
- Angiographically confirmed abnormal bronchial or intercostal artery blood supply to the fistula and anatomy suitable for NBCA with coil embolization;
- Age ≤75 years, ECOG performance status ≤2, and predicted survival ≥3 months.
- Coagulation function was basically normal.
Key exclusion criteria (6 listed)
- Had a history of severe allergy or contraindication to NBCA glue, iodine contrast agent or coil materials;
- Severe cardiopulmonary dysfunction (e.g., NYHA class III-IV, FEV1 < 30% predicted, uncontrolled pulmonary hypertension);
- Angiographic abnormalities of the target vessel anatomy (e.g., severe tortuosity, stenosis, or occlusion) prevented the catheter from safely reaching the target embolization site;
- Active systemic infection (e.g., sepsis, active tuberculosis) or uncontrolled local infection;
- Other major organ failure (Child-Pugh C cirrhosis, eGFR < 30 mL/min/1.73m²);
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 |
|---|---|---|
| Interventional therapyThe fistula was occluded by coil and NBCA glue. | Procedure or surgery | Interventional THERAPY Group |
Primary outcome
OS，Overall Survival
Time frame: From the time of treatment to the death from any cause, assessed up to 50 months.
The patient received treatment until death.
PFS，Progress Free Survival
Time frame: From the time of treatment to tumor progression or date of death from any cause, whichever came first, assessed up to 50 months
Time of progression or death of the patient.
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 15 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Osteosarcoma Metastatic
RecruitingPhase 3
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Osteosarcoma, Pediatric Osteosarcoma
Active, not recruitingPhase 1/2
Aerosolized Aldesleukin in Treating Patients With Lung Metastases
Metastatic Malignant Neoplasm in the Lung, Metastatic Melanoma
RecruitingPhase 2
XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma
Metastatic Leiomyosarcoma, Unresectable Leiomyosarcoma
RecruitingPhase 2
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
Locally Advanced Osteosarcoma, Metastatic Osteosarcoma
Not yet recruitingPhase 1/2
A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma
Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma Metastatic, run by Ruijin Hospital.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Zhongmin Wang (+8613901848333, wzm11896@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS，Overall Survival (time frame: From the time of treatment to the death from any cause, assessed up to 50 months.). 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?
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 15 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.