Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB-BACE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization) | Device | 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. |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided