Bronchial Artery Chemoembolization (BACE) Combination Therapy for Advanced NSCLC

NCT07738367 | Enrolling By Invitation Phase 2

• 1 other identifier: K2026-125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer(NSCLC)

Keywords

Non-Small Cell Lung Cancer(NSCLC); Bronchial Arterial Chemoembolization(BACE); Interventional Radiology

Outcome Measures

Primary Outcomes (2)

• Local Time to Progression (Local TTP) of target intrathoracic lesions

  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.

  Up to 24 months after the first BACE treatment

• Incidence and severity of treatment-related adverse events (TRAEs)

  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.

  From the first BACE procedure until 30 days after the last study treatment

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 24 months after initial BACE treatment

• Disease Control Rate (DCR)

  Up to 24 months after initial BACE treatment

• Progression-Free Survival (PFS)

  Up to 36 months after enrollment

• Overall Survival (OS)

  Up to 36 months after enrollment

Other Outcomes (1)

• Dynamic assessment of the local tumor immune microenvironment before and after BACE treatment

  before each BACE treatment, and at 21 ± 3 days after BACE treatment

Study Arms (1)

Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm

EXPERIMENTAL

This is an open-label, prospective single-arm Phase II clinical trial. It aims to evaluate the efficacy and safety of bronchial arterial chemoembolization (BACE) combination therapy in adult patients with advanced non-small cell lung cancer (NSCLC) who have no standard treatment options left.

Procedure: Bronchial Arterial Chemoembolization (BACE); Drug: Systemic anti-tumor combination medications

Interventions

Bronchial Arterial Chemoembolization (BACE) PROCEDURE

Interventional chemoembolization procedure targeting tumor-feeding bronchial arteries for local tumor control.

Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm

Systemic anti-tumor combination medications DRUG

Systemic chemotherapy, immune checkpoint inhibitors or targeted agents administered in combination with BACE procedure per protocol，the BACE regimen was planned for 2 cycles

Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
• Histopathologically confirmed advanced non-small cell lung cancer (NSCLC), with at least one measurable target lesion defined by RECIST Version 1.1.
• 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.
• Target lung lesions are suitable for bronchial arterial chemoembolization (BACE), as assessed by interventional radiology specialists.
• Adequate function of major vital organs.
• Able to provide written informed consent prior to any study-related procedures.

You may not qualify if:

• Histopathological confirmation of mixed small cell lung cancer components.
• Active bleeding or coagulation disorders.
• Severe hypersensitivity to contrast media, chemotherapeutic agents, or combined study medications.
• Extensive and rapidly progressive intra-pulmonary or extra-pulmonary metastatic lesions.
• Angiography during the procedure shows that superselective catheterization cannot completely avoid hazardous blood vessels such as spinal arteries.
• Severe pre-existing hepatic, renal, cardiac, or pulmonary dysfunction.
• Estimated survival time less than 3 months.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Related Publications (12)

• Cui 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 RESULT

• Zhao 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 RESULT

• Shang 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 RESULT

• Zhang 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 RESULT

• Liu 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 RESULT

• Zhang 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 RESULT

• Xiang 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.

  PMID: 38655260 RESULT

• Koban MU, Hartmann M, Amexis G, Franco P, Huggins L, Shah I, Karachaliou N. Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. Clin Cancer Res. 2024 Nov 1;30(21):4822-4833. doi: 10.1158/1078-0432.CCR-24-0741.

  PMID: 39177967 RESULT

• Dong S, Li X, Huang Q, Li Y, Li J, Zhu X, Xue C, Chen R, Zeng Y, Wu J, Zhong Y, Hu S. Resistance to immunotherapy in non-small cell lung cancer: Unraveling causes, developing effective strategies, and exploring potential breakthroughs. Drug Resist Updat. 2025 Jul;81:101215. doi: 10.1016/j.drup.2025.101215. Epub 2025 Feb 25.

  PMID: 40081220 RESULT

• Gang X, Yan J, Li X, Shi S, Xu L, Liu R, Cai L, Li H, Zhao M. Immune checkpoint inhibitors rechallenge in non-small cell lung cancer: Current evidence and future directions. Cancer Lett. 2024 Nov 1;604:217241. doi: 10.1016/j.canlet.2024.217241. Epub 2024 Sep 10.

  PMID: 39260670 RESULT

• Su PL, Furuya N, Asrar A, Rolfo C, Li Z, Carbone DP, He K. Recent advances in therapeutic strategies for non-small cell lung cancer. J Hematol Oncol. 2025 Mar 27;18(1):35. doi: 10.1186/s13045-025-01679-1.

  PMID: 40140911 RESULT

• Planchard D, Popat S, Kerr K, Novello S, Smit EF, Faivre-Finn C, Mok TS, Reck M, Van Schil PE, Hellmann MD, Peters S; ESMO Guidelines Committee. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192-iv237. doi: 10.1093/annonc/mdy275. No abstract available.

  PMID: 30285222 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jinghui Lin Jinghui Lin, Bachelor of Medicine(BM)

  Fujian Cancer Hospital

  STUDY CHAIR

• Shiguang Chen Shiguang Chen, Doctor of Medicine (MD)

  Fujian Cancer Hospital

  STUDY CHAIR

• Zhuting Fang Zhuting Fang, Doctor of Medicine (MD)

  Fujian Cancer Hospital

  STUDY DIRECTOR

• Zhiyong He Zhiyong He, Master of Medicine (MM)

  Fujian Cancer Hospital

  STUDY DIRECTOR

• Qiang Wang Qiang Wang, Bachelor of Medicine(BM)

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Lihong Weng Lihong Weng, Master of Medicine (MM)

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Dong Lin Dong Lin, Bachelor of Medicine（BM）

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Meifang Li Meifang Li, Bachelor of Medicine（BM）

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Department of Thoracic Medical Oncology

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 31, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)