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

Status: Not yet enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)

Study type: Interventional

Funder types: Other

Identifiers

NCT04825925

E20210168A

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

DEB-BACE

Experimental group

Treatment:

Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)