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 Hospital0 sites60 target enrollmentMay 1, 2021

ConditionsCarcinoma, Non-Small-Cell Lung

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 60
Primary Endpoint: Progression-free survival (PFS)
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 1, 2021

End Date

October 1, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients ≥ 18 years old, of any sex;
•Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
•Confirmed TNM stage is II-III of NSCLC;
•Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
•Life expectancy of \> 3 months;
•Patients volunteered to participate in this study and signed informed consent, with good compliance;

Exclusion Criteria

•Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
•A history combined with other malignant tumors and not cured;
•WBC\<3×109/L、LYM\<1.5×109/L、NLR≥3、PLT\<50×109/L、HGB\<90 g/L;
•Insufficient of liver and renal function (Cr\>176.8 µmol/L; AST and/or ALT\>2 folds of normal value)；
•Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
•Combined with active affection and need antibiotic treatment;
•Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms;
•Known to be hypersensitive to contrast agent;
•Pregnant or breastfeeding women;

Outcomes

Primary Outcomes

Progression-free survival (PFS)

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

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

Secondary Outcomes

Disease control rate (DCR)(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 or up to 36 months)
Objective response rate (ORR)(1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months)
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)
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)
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)
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)
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)