Recruiting
Phase 2

Transarterial Chemoembolization

Sponsor:

City of Hope Medical Center

Code:

NCT05672108

Conditions

Lung Non-Small Cell Carcinoma

Mediastinal Neoplasm

Pleural Neoplasm

Lung Metastases From Any Primary

Endobronchial Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Ethiodized Oil

Mitomycin

Transarterial Chemoembolization

Tris-acryl Gelatin Microspheres

Study Details

Brief summary:

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.

Conditions

Lung Non-Small Cell Carcinoma

Mediastinal Neoplasm

Pleural Neoplasm

Lung Metastases From Any Primary

Endobronchial Metastases

Study ID

NCT05672108

Start date

May 12, 2023

Status verified date

Mar, 2026

Completion date

Oct 28, 2027

Anticipated

Primary completion date

Oct 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 become pregnant
  • Breast feeding
  • Altered mental status that would interfere with consent or follow-up
  • Platelets \< 50,000 (after transfusion, if needed)
  • International normalized ratio (INR) \> 2 (after transfusion, if needed)
  • Hemoglobin \< 7 (after transfusion, if needed)
  • Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)
  • Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
  • Allergy to lipiodol or mitomycin
  • Allergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedication
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lung chemoembolization

Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.

Interventions

Computed Tomography

Undergo CT

Ethiodized Oil

Given IA

Mitomycin

Given IA

Transarterial Chemoembolization

Undergo TACE

Tris-acryl Gelatin Microspheres

Given IA

Primary outcome measure

  • Local progression free survival [ Time Frame: Time from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months ]
  • Incidence of adverse events [ Time Frame: Up to 3 months after the last chemoembolization procedure ]

Central Contacts and Locations

Central contacts

Franz Edward Boas, MD

626-218-8708fboas@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Franz E. Boas

626-218-8708fboas@coh.org

Principal Investigator:

Franz E. Boas

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Stephen B. Solomon, MD

212-639-5012solomons@mskcc.org

Principal Investigator:

Stephen B. Solomon, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-03-05.