Phase II Trial of Lung Chemoemobolization

March 3, 2026 updated by: City of Hope Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Franz Edward Boas, MD
  • Phone Number: 626-218-8708
  • Email: fboas@coh.org

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Franz E. Boas
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Stephen B. Solomon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Procedure: Transarterial Chemoembolization
Undergo TACE
Other Names:
  • TACE
Drug: Ethiodized Oil
Given IA
Other Names:
  • Ethiodol
  • Lipiodol
  • Iodized Oil
Drug: Mitomycin
Given IA
Other Names:
  • Mutamycin
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycine
  • NCI-C04706
Device: Tris-acryl Gelatin Microspheres
Given IA
Other Names:
  • Embospheres
  • TAGM
  • Trisacryl Gelatin Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method.
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
Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability.
Up to 3 months after the last chemoembolization procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (best response)
Time Frame: Within 3 months of treatment
Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
Within 3 months of treatment
Overall survival
Time Frame: Up to 9 months
Will be estimated using the Kaplan-Meier method.
Up to 9 months
Progression-free survival
Time Frame: Up to 9 months
Will be estimated using the Kaplan-Meier method.
Up to 9 months
Bronchial versus pulmonary artery blood supply
Time Frame: Up to 9 months
Percentage of treatments where target tumors were supplied by bronchial artery, non-bronchial systemic artery, or pulmonary artery, based on catheter angiography. Confidence intervals of proportions will be estimated using the equal-tailed Jeffreys prior interval.
Up to 9 months
Lipiodol retention in treated tumors
Time Frame: 4-6 weeks post-procedure
Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.
4-6 weeks post-procedure
Growth of TACE targeted lesions versus non-TACE targeted lesions
Time Frame: 4-6 weeks post-procedure
Percentage change in size (largest diameter) of the largest treated, compared to the largest untreated tumor will be evaluated using the Wilcoxon signed-rank test.
4-6 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Franz E Boas, MD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22067 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2022-10436 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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