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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04825925
• Other study ID #: E20210168A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate (ORR)	Proportion of patients with reduction in stable in tumor burden of a predefined amount	1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
Secondary	Disease control rate (DCR)	Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount	1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
Secondary	Overall survival (OS)	Time from the first DEB-BACE treatment to death from any cause or the end of the study	Time from the first DEB-BACE treatment to death or up to 36 months
Secondary	Recurrence rate of hemoptysis	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	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
Secondary	Tumor biomarker (CEA, SCC)	Changes of tumor biomarkers	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
Secondary	Quality of life score (EORTC, QLQ-30)	Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores	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
Secondary	Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (ECOG PS)	Changes of 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
Secondary	VAS pain grade	Changes of 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