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 Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DEB-BACE
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Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)
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.
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Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) [Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 months]
Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death
Secondary Outcome Measures
- Objective response rate (ORR) [1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months]
Proportion of patients with reduction in stable in tumor burden of a predefined amount
- Disease control rate (DCR) [1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months]
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
- Overall survival (OS) [Time from the first DEB-BACE treatment to death or up to 36 months]
Time from the first DEB-BACE treatment to death from any cause or the end of the study
- Recurrence rate 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]
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
- Tumor biomarker (CEA, SCC) [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]
Changes of tumor biomarkers
- Quality of life score (EORTC, QLQ-30) [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]
Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (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]
Changes of ECOG PS
- 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]
Changes of VAS pain grade
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients ≥ 18 years old, of any sex;
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Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
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Confirmed TNM stage is II-III of NSCLC;
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Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
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Life expectancy of > 3 months;
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Patients volunteered to participate in this study and signed informed consent, with good compliance;
Exclusion Criteria:
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Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
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A history combined with other malignant tumors and not cured;
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WBC<3×109/L、LYM<1.5×109/L、NLR≥3、PLT<50×109/L、HGB<90 g/L;
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Insufficient of liver and renal function (Cr>176.8 µmol/L; AST and/or ALT>2 folds of normal value)；
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Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
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Combined with active affection and need antibiotic treatment;
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Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms;
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Known to be hypersensitive to contrast agent;
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Pregnant or breastfeeding women;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E20210168A