Carcinoma, Non-Small-Cell Lung
Conditions
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
Interventions
DEVICEDEB-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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years old, of any sex; 2. Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）; 3. Confirmed TNM stage is II-III of NSCLC; 4. Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)； 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2; 6. Life expectancy of \> 3 months; 7. Patients volunteered to participate in this study and signed informed consent, with good compliance;
Exclusion criteria
1. Patients received interventional therapy (I seeds implantation, Ablation, BACE) before; 2. A history combined with other malignant tumors and not cured; 3. WBC\<3×109/L、LYM\<1.5×109/L、NLR≥3、PLT\<50×109/L、HGB\<90 g/L; 4. Insufficient of liver and renal function (Cr\>176.8 µmol/L; AST and/or ALT\>2 folds of normal value)； 5. Combined with uncorrectable coagulation dysfunction or active massive hemoptysis; 6. Combined with active affection and need antibiotic treatment; 7. Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms; 8. Known to be hypersensitive to contrast agent; 9. Pregnant or breastfeeding women;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Outcome results
None listed