Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments

Study Overview
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Brief Summary
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This is a multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients who failed, refused or ineligible to receive standard treatments

Official Title
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Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years old, of any sex; Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）; Confirmed TNM stage is II-III of NSCLC; Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)； Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2; Life expectancy of > 3 months; Patients volunteered to participate in this study and signed informed consent, with good compliance; Exclusion Criteria: Patients received interventional therapy (I seeds implantation, Ablation, BACE) before; A history combined with other malignant tumors and not cured; WBC<3×109/L、LYM<1.5×109/L、NLR≥3、PLT<50×109/L、HGB<90 g/L; Insufficient of liver and renal function (Cr>176.8 µmol/L; AST and/or ALT>2 folds of normal value)； Combined with uncorrectable coagulation dysfunction or active massive hemoptysis; Combined with active affection and need antibiotic treatment; Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms; Known to be hypersensitive to contrast agent; Pregnant or breastfeeding women;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB-BACE<br> | Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)<br>* Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, the Platinum was infused. BAI (Bronchial Arterial Infusion ) chemotherapy was followed by DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with Vinorelbine were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death | Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Proportion of patients with reduction in stable in tumor burden of a predefined amount | 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months | 
| Disease control rate (DCR) | Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount | 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months | 
| Overall survival (OS) | Time from the first DEB-BACE treatment to death from any cause or the end of the study | Time from the first DEB-BACE treatment to death or up to 36 months | 
| Recurrence rate of hemoptysis | For the NSCLC subjects with hemoptysis, the patients completely or almost completely hemostasis were treated with the first treatment of DEB-BACE. If hemoptysis occurs during follow-up, it is recurrent of hemoptysis | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months | 
| Tumor biomarker (CEA, SCC) | Changes of tumor biomarkers | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months | 
| Quality of life score (EORTC, QLQ-30) | Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months | 
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (ECOG PS) | Changes of ECOG PS | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months | 
| VAS pain grade | Changes of VAS pain grade | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months |