Clinical trial · Interventional
Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC
Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy(BAI) combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAI combine with DEB-BACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BAI combine with DEB-BACE
- description
- Procedure: BAI combine with DEB-BACE: bronchial infusion chemotherapy combined with drug-loaded microsphere embolization of EqualSpheres 1. First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20 \~30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP (40 \~ 60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding artery.
- interventionNames
- Procedure: BAI combine with DEB-BACE
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 3 years
- description
- PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years old, male and female; 2. According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology; 3. TNM stages were III-IV; 4. Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy); 5. ECOG PS ≤2; 6. Expected survival \> 3 months; 7. Sign the informed consent voluntarily, and the compliance is good. Exclusion Criteria: 1. Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment); 2. Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis; 3. Have had or currently having other primary malignant tumors; 4. White blood cell \< 3×109/L, platelet count \< 50×109/L, HGB \< 90 g/L; 5. Hepatic and renal insufficiency (creatinine \> 2 mg/L; AST and/or ALT \> 2 times the normal upper limit); 6. Coagulation dysfunction (INR \> 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy; 7. Patients with active infection requiring antibiotic treatment; 8. Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms; 9. contrast agent allergy; 10. Women with pregnancy or lactation.
References
Publications (0)
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