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Bronchial Artery Chemoembolization (BACE) Combination Therapy for Advanced NSCLC
Sponsor: Fujian Cancer Hospital
Summary
Patients with advanced non-small cell lung cancer (NSCLC) who experience disease progression after standard systemic therapies or are unable to tolerate such therapies have limited subsequent treatment options. Bronchial arterial chemoembolization (BACE) is a locoregional interventional procedure that delivers chemotherapeutic agents directly into tumor-feeding bronchial arteries, followed by arterial embolization, with the aim of increasing local drug exposure and reducing tumor blood supply. This prospective, open-label, single-arm Phase II study will evaluate the efficacy and safety of BACE-based combination therapy in adult patients with advanced NSCLC who have no remaining standard treatment options and whose target intrathoracic lesions are considered suitable for BACE. Approximately 20 eligible participants are planned for enrollment between April 2026 and April 2028. All enrolled participants will receive protocol-specified BACE in combination with systemic anti-tumor therapy. Treatment selection and administration will be performed according to the study protocol, taking into account the participant's molecular characteristics, prior treatments, clinical condition, and treatment tolerance. The study will primarily assess local tumor control and the safety of the combined treatment strategy. Tumor response and disease progression will be evaluated by contrast-enhanced imaging according to RECIST criteria, and adverse events will be assessed using CTCAE Version 5.0. Additional assessments will include objective tumor response, disease control, progression-free survival, and overall survival. Exploratory analyses will investigate the systemic pharmacokinetics of chemotherapeutic agents administered during BACE and potential treatment-related changes in the tumor immune microenvironment.
Official title: A Single-Arm Phase II Study of Bronchial Artery Chemoembolization (BACE) Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Without Standard Treatment Options
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-04-09
Completion Date
2028-10-30
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
Bronchial Arterial Chemoembolization (BACE)
Interventional chemoembolization procedure targeting tumor-feeding bronchial arteries for local tumor control.
Systemic anti-tumor combination medications
Systemic chemotherapy, immune checkpoint inhibitors or targeted agents administered in combination with BACE procedure per protocol，the BACE regimen was planned for 2 cycles
Locations (1)
Fujian Cancer Hospital
Fuzhou, Fujian, China