Clinical trial · Interventional
Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure
Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure: A Prospective, Multicenter, Randomized, Open, Double-arm Clinical Trial
- 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 study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug-eluting beads bronchial arterial chemoembolization | Procedure | — | UNRESOLVED |
| Programmed Cell Death Protein 1 Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination Treatment Group
- description
- Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.
- interventionNames
- Procedure: Drug-eluting beads bronchial arterial chemoembolization
- Drug: Programmed Cell Death Protein 1 Inhibitor
- type
- ACTIVE_COMPARATOR
- label
- Single Treatment Group
- description
- Only receive drug-eluting beads bronchial arterial chemoembolization treatment.
- interventionNames
- Procedure: Drug-eluting beads bronchial arterial chemoembolization
Primary outcomes (1)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age more than 18 years old, no gender limit. * According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology. * Tumor Node Metastasis (TNM) staging is II-III. * According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation. * Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2. * Estimated survival time is more than 3 months. * The patient has signed informed consent. Exclusion Criteria: * The patient has previously received interventional therapy \[iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy\], or received immunotherapy during the first-line standard treatment. * The patient is accompanied by other malignant tumors and had not been cured. * White blood cell \< 3×10\*9/L, absolute value of neutrophils \< 1.5×10\*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count \< 50×10\*9/L, hemoglobin concentration \< 90 g/L. * Liver and kidney dysfunction (creatinine \> 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 times the upper limit of normal). * Uncorrectable coagulopathy or active hemoptysis. * Patient with active infections requires antibiotic treatment. * Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms. * Allergy to contrast agents. * Women with pregnancy or lactation.
References
Publications (0)
Data not yet available