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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
2. Histopathologically confirmed advanced non-small cell lung cancer (NSCLC), with at least one measurable target lesion defined by RECIST Version 1.1.
3. Two eligible patient subgroups:
Patients with negative driver gene alterations: experienced disease progression or intolerable toxicity after platinum-based doublet chemotherapy combined with PD-1/PD-L1 immune checkpoint inhibitors; Patients with positive driver gene mutations (e.g., EGFR, ALK): experienced disease progression or unacceptable adverse reactions after corresponding targeted therapy plus at least one line of systemic chemotherapy.
4. Target lung lesions are suitable for bronchial arterial chemoembolization (BACE), as assessed by interventional radiology specialists.
5. Adequate function of major vital organs.
6. Able to provide written informed consent prior to any study-related procedures.
Exclusion Criteria:
1. Histopathological confirmation of mixed small cell lung cancer components.
2. Active bleeding or coagulation disorders.
3. Severe hypersensitivity to contrast media, chemotherapeutic agents, or combined study medications.
4. Extensive and rapidly progressive intra-pulmonary or extra-pulmonary metastatic lesions.
5. Angiography during the procedure shows that superselective catheterization cannot completely avoid hazardous blood vessels such as spinal arteries.
6. Severe pre-existing hepatic, renal, cardiac, or pulmonary dysfunction.
7. Estimated survival time less than 3 months.
Primary outcome measure(s)
Local Time to Progression (Local TTP) of target intrathoracic lesions — Up to 24 months after the first BACE treatment The time from the date of BACE treatment to the first documentation of local progression of target lung lesions, assessed by contrast-enhanced chest CT scan per RECIST criteria.
Incidence and severity of treatment-related adverse events (TRAEs) — From the first BACE procedure until 30 days after the last study treatment All adverse events occurring during the study period, graded per CTCAE v5.0, including laboratory abnormalities and procedural complications related to BACE and combined systemic anti-tumor therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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