Recruiting nowPhase 2
What this trial is trying to do
The researchers think that delivering mitomycin directly into the artery feeding a lung tumour, mixed with Lipiodol (an oily drug carrier), and then blocking that artery with small beads could keep a high chemotherapy dose in the tumour while cutting off its oxygen and nutrients. This phase II trial is testing the procedure in people with non-small-cell lung cancer or lung metastases.
The trial asks whether this local treatment can control the treated tumours for longer, measured as local progression-free survival—the time before those tumours grow again. It is not comparing TACE with another treatment, so it cannot show whether it helps people live longer or is better overall than standard care.
Worth knowing: This is a small, non-randomised study with no comparison group, and its main outcome is control of the treated tumour rather than overall survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05672108 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 30 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | City of Hope Medical Center |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Computed Tomography
- Drug Ethiodized Oil
- Drug Mitomycin
- Procedure Transarterial Chemoembolization
- Device Tris-acryl Gelatin Microspheres
What it is measuring
Local progression free survival
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy
- Lung-dominant disease (majority of active tumor volume is in the chest)
- At least 18 years old
Exclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Oxygen saturation < 92% on room air
- Forced expiratory volume in 1 second (FEV1) < 60%
- No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all < 1 cm)
- Life expectancy < 6 months
- Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [MRI], or direct pressure measurement)
- Recent pulmonary embolism (within 3 months)
- Pulmonary arteriovenous malformation
- Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
- Symptomatic heart failure (American College of Cardiology [ACC]/American Heart Association [AHA] stage C or D)
- Left bundle branch block (contraindication to pulmonary angiography)
- Renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2)
- Pregnancy or intent to bec…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 2 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05672108, registered by City of Hope Medical Center on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.