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

Not Applicable

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)

• Registration Number: NCT04825925
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-12
• Study Start: 2021-05-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEB-BACE	DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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 Outcome Measures

Name	Time	Method
Disease control rate (DCR)	1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months	Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Overall survival (OS)	Time from the first DEB-BACE treatment to death or up to 36 months	Time from the first DEB-BACE treatment to death from any cause or the end of the study
Objective response rate (ORR)	1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months	Proportion of patients with reduction in stable in tumor burden of a predefined amount
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	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
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	Changes of tumor biomarkers
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	Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores
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	Changes of ECOG PS
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	Changes of VAS pain grade