Bronchial Artery Chemoembolization (BACE) Combination Therapy for Advanced NSCLC

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)

Interventions

PROCEDURE

Bronchial Arterial Chemoembolization (BACE)

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

DRUG

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

Sponsors & Collaborators

• Fujian Cancer Hospital

  lead OTHER_GOV

Principal Investigators

• Jinghui Lin Jinghui Lin, Bachelor of Medicine(BM) · Fujian Cancer Hospital

• Shiguang Chen Shiguang Chen, Doctor of Medicine (MD) · Fujian Cancer Hospital

• Zhuting Fang Zhuting Fang, Doctor of Medicine (MD) · Fujian Cancer Hospital

• Zhiyong He Zhiyong He, Master of Medicine (MM) · Fujian Cancer Hospital

• Qiang Wang Qiang Wang, Bachelor of Medicine(BM) · Fujian Cancer Hospital

• Lihong Weng Lihong Weng, Master of Medicine (MM) · Fujian Cancer Hospital

• Dong Lin Dong Lin, Bachelor of Medicine（BM） · Fujian Cancer Hospital

• Meifang Li Meifang Li, Bachelor of Medicine（BM） · Fujian Cancer Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-09

Primary Completion

2028-04-30

Completion

2028-10-30

Countries

• China

Study Locations