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

NCT04825925 | Unknown

• 1 other identifier: E20210168A
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

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

  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 (8)

• Objective response rate (ORR)

  1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months

• 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

• 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

Study Arms (1)

DEB-BACE

EXPERIMENTAL

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

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.

DEB-BACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 12, 2021

Record last verified: 2021-03