DEB-BACE for Primary Lung Cancer: A Retrospective, Single-Arm, Multicenter Study on Efficacy and Safety

NCT07072299 | Not Yet Recruiting

• 1 other identifier: 2025-KY-0872-001
• Study Type: observational
• Target: 1,213
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a retrospective, single-arm, multicenter clinical study designed to evaluate the efficacy and safety of DEB-BACE (Drug-Eluting Bead Bronchial Artery Chemoembolization) in the treatment of primary lung cancer.

Conditions

Lung Cancer Patients

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to mRECIST 1.1 criteria

  up to 1 years

Secondary Outcomes (2)

• PFS

  up to 1 years

• OS

  up to1 years

Interventions

DEB-BACE PROCEDURE

Drug-Eluting Bead microspheres used for embolization: Drug-Eluting Bead microspheres 1tube was loaded and adsorbed chemotherapy. End point of embolization: stagnation of blood flow in tumor feeding artery

Eligibility Criteria

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

Study Population

Primary Lung Cancer

You may qualify if:

• \. Age ≥ 18 years old, gender unrestricted; 2. Diagnosed with primary lung cancer based on the Primary Lung Cancer Diagnosis and Treatment Guidelines (2022 Edition) through histopathological examination; 3. At least one measurable lesion (evaluated according to RECIST 1.1 criteria); 4. Previously received at least one DEB-BACE treatment; 5. ECOG PS score ≤ 2; 6. Complete patient case records.

You may not qualify if:

• \. Presence of extensive and uncontrolled extrapulmonary brain metastasis lesions; 2. Irreversible coagulation dysfunction within a short period of time; 3. Uncontrollable hypertension, diabetes, or significant cardiovascular diseases with obvious symptoms; 4. Allergy to contrast agent; 5. Pregnant or lactating women; 6. Patients whose condition, as judged by the investigator, poses a serious threat to patient safety or hinders their participation in the study.

Sponsors & Collaborators

• Gang Wu, MD: lead

Central Study Contacts

Gang Wu

CONTACT

+86 139 3857 0175; wuganghenan2004@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share