Bronchial Artery Chemoembolization (BACE) Combination Therapy for Advanced NSCLC

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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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.

• RESULTCui W, Li J, Tian J, Deng Y, Chen J, Cui J, Wang Q, Mai Q, Chen X, Zhang J, Xu R. Drug-eluting beads bronchial arterial chemoembolization in advanced and standard treatment-refractory/ineligible non-small cell lung cancer. Quant Imaging Med Surg. 2025 Apr 1;15(4):3458-3468. doi: 10.21037/qims-24-1789. Epub 2025 Mar 28. PMID 40235787
• RESULTZhao YW, Liu S, Qin H, Sun JB, Su M, Yu GJ, Zhou J, Gao F, Wang RY, Zhao T, Zhao GS. Efficacy and safety of CalliSpheres drug-eluting beads for bronchial arterial chemoembolization for refractory non-small-cell lung cancer and its impact on quality of life: A multicenter prospective study. Front Oncol. 2023 Apr 14;13:1110917. doi: 10.3389/fonc.2023.1110917. eCollection 2023. PMID 37124525
• RESULTShang B, Li J, Wang X, Li D, Liang B, Wang Y, Han X, Dou W, Chen G, Shang J, Jiang S. Clinical effect of bronchial arterial infusion chemotherapy and CalliSpheres drug-eluting beads in patients with stage II-IV lung cancer: A prospective cohort study. Thorac Cancer. 2020 Aug;11(8):2155-2162. doi: 10.1111/1759-7714.13522. Epub 2020 Jun 30. PMID 32603550
• RESULTZhang F, Liu Y. Clinical study on bronchial artery chemoembolization for unresectable non-small cell lung cancer. Front Oncol. 2025 Sep 3;15:1591752. doi: 10.3389/fonc.2025.1591752. eCollection 2025. PMID 40969256
• RESULTLiu Y, Zhang X, Zhang F, Song W. Bronchial artery chemoembolization in the treatment of refractory central lung cancer with atelectasis. Front Oncol. 2024 Jun 12;14:1343324. doi: 10.3389/fonc.2024.1343324. eCollection 2024. PMID 38933450
• RESULTZhang F, Liu Y. Transcatheter arterial chemoembolization for lung malignant tumors. Front Oncol. 2025 Apr 16;15:1551644. doi: 10.3389/fonc.2025.1551644. eCollection 2025. PMID 40308513
• RESULTXiang Y, Liu X, Wang Y, Zheng D, Meng Q, Jiang L, Yang S, Zhang S, Zhang X, Liu Y, Wang B. Mechanisms of resistance to targeted therapy and immunotherapy in non-small cell lung cancer: promising strategies to overcoming challenges. Front Immunol. 2024 Apr 9;15:1366260. doi: 10.3389/fimmu.2024.1366260. eCollection 2024.