Clinical trial NCT04825925: Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 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:
measure: Objective response rate (ORR)
timeFrame: 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
measure: Disease control rate (DCR)
timeFrame: 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
measure: Overall survival (OS)
timeFrame: Time from the first DEB-BACE treatment to death or up to 36 months
measure: Recurrence rate of hemoptysis
timeFrame: 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
measure: Tumor biomarker (CEA, SCC)
timeFrame: 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
measure: Quality of life score (EORTC, QLQ-30)
timeFrame: 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
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (ECOG PS)
timeFrame: 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
measure: VAS pain grade
timeFrame: 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
Other outcomes:
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