By InvitationPhase 2

Bronchial Artery Chemoembolization (BACE) Combination Therapy for Advanced NSCLC

China20 participantsStarted 2026-04-09

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a procedure called bronchial artery chemoembolization — can you explain what that involves and how it's different from the chemotherapy or targeted therapy I might already be considering?
2Since this is a Phase 2 trial, the researchers are still building evidence on how well this works and how safe it is — what do you think is known so far about the risks, and how does that uncertainty factor into whether this might be right for me?
3The trial is 'enrolling by invitation only' — do you know whether I would even be considered for an invitation, and what criteria they're using to select patients?
4One of the main things they're measuring is how long it takes for tumors in the chest to start growing again after treatment — given my specific tumor locations and stage, is that the most important outcome for my situation, or should I be prioritizing something else like overall survival?
5Are there standard advanced NSCLC treatments I should try first before exploring this trial, and how would participating in this study affect my ability to access those options later if I need them?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 24 months after the first BACE treatment

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

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

Trial details

NCT IDNCT07738367

SponsorFujian Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-04-30

View on ClinicalTrials.gov More Non-small Cell Lung Cancer(NSCLC) trials