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

Tianjin Medical University Cancer Institute and Hospital60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death

Time frame: Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 months

Secondary Outcomes

Objective response rate (ORR)

Proportion of patients with reduction in stable in tumor burden of a predefined amount

Time frame: 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

Time frame: 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 frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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