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An exploratory study of the efficacy and safety of polyvinyl alcohol embolization microspheres for bronchial artery chemoembolization in the treatment of lung cancer complicated with hemoptysis

An exploratory study of the efficacy and safety of polyvinyl alcohol embolization microspheres for bronchial artery chemoembolization in the treatment of lung cancer complicated with hemoptysis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088812
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-08-31
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Experimental group:Polyvinyl alcohol embolization microspheres are used for bronchial chemoembolization

Sponsors

Cardiolink Science Medical Technology Development Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years old, gender is not limited; (2) Patients with lung cancer who refuse standard therapy or do not respond to standard therapy with hemoptysis; (3) CT angiography or angiography shows the presence of bronchial arteries or other systemic arteries involved in the blood supply to the tumor (4) Expected survival > 3 months; (5) ECOG score = 2 points; (6) Patients who agree to participate in this study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe pulmonary fibrosis and pulmonary hypertension and those with reduced pulmonary circulation blood supply due to various reasons; (2) Patients with uncontrolled skin infection at the puncture site and inability to change the puncture site, systemic infection, high fever (body temperature > 38.5 °C); (3) extensive and uncontrolled extrapulmonary metastatic disease; (4) Patients with poor control of large pleural effusion and pericardial effusion; (5) Patients with severe liver, kidney, heart and lung insufficiency may have severe dehydration and nutritional and metabolic disorders that cannot be corrected in a short period of time or improver; (6) Those who cannot be intubated beyond the selection of intubation during the operation, and completely avoid dangerous blood vessels such as spinal arteries; (7) Lung damage caused by tuberculosis or other causes; (8) Patients requiring emergency intervention to stop bleeding; (9) Patients with a history of bronchial arterial chemoembolization of the target lesion; (10) Patients who cannot tolerate anesthesia, contraindicated or allergic to surgical drugs; (11) Severe liver impairment (AST or ALT more than 3 times the upper limit of normal) or severe renal impairment (creatinine > 1.5 times the upper limit of normal); (12) Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time (prothrombin time> 18 s); (13) Patients with white blood cell < 3.0×10^9/L, neutrophil < 1.5×10^9/L, hemoglobin < 80 g/L, red blood cell < 2.0×10^12/L, platelet count < 50×10^9/L (except for patients with hypersplenism and chemotherapy myelosuppression) (14) Pregnant or lactating females; (15) Those who are participating in clinical trials of other medical devices or drugs (16) Other circumstances judged by the investigator to be unsuitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Immediate clinical success rate;

Secondary

MeasureTime frame
Technical success rate;Device performance evaluation;

Countries

China

Contacts

Public ContactJianFei Tu

Lishui Central Hospital

jianfei1133@163.com+86 136 4678 2878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026