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

NCT ID: NCT04825925

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEB-BACE

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

E20210168A

Identifier Type: -

Identifier Source: org_study_id