Phase II Trial of Lung Chemoemobolization

Last updated: March 3, 2026
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Colorectal Cancer

Colon Cancer

Treatment

Ethiodized Oil

Transarterial Chemoembolization

Computed Tomography

Clinical Study ID

NCT05672108
22067
22067
P30CA033572
NCI-2022-10436
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinaltumors that are progressing on systemic therapy (or the patient cannot toleratesystemic therapy), and that are not amenable to resection, thermal ablation, orablative radiation therapy

  • Lung-dominant disease (majority of active tumor volume is in the chest)

  • At least 18 years old

Exclusion

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 lungnodules are all < 1 cm)

  • Life expectancy < 6 months

  • Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magneticresonance 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 HeartAssociation [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 / diphenhydraminepremedication

  • Any condition that, in the opinion of the investigator, would interfere withevaluation of the investigational product, or that would affect subject safety

Study Design

Total Participants: 30
Treatment Group(s): 5
Primary Treatment: Ethiodized Oil
Phase: 2
Study Start date:
May 12, 2023
Estimated Completion Date:
October 28, 2027

Study Description

PRIMARY OBJECTIVE:

I. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.

OUTLINE:

Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

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