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RecruitingInterventionalPhase 2

Phase II Trial of Lung Chemoemobolization

NCT ID: NCT05672108Sponsor: City of Hope Medical CenterLast updated: 2026-03-05

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.

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.

Arms & interventions

  • ProcedureComputed Tomography

    Undergo CT

  • DrugEthiodized Oil

    Given IA

  • DrugMitomycin

    Given IA

  • ProcedureTransarterial Chemoembolization

    Undergo TACE

  • DeviceTris-acryl Gelatin Microspheres

    Given IA

Outcome measures

Primary

  • Local progression free survival

    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 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

    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.

    Time frame: Up to 3 months after the last chemoembolization procedure

Secondary

  • Objective response rate (best response)

    Time frame: Within 3 months of treatment

  • Overall survival

    Time frame: Up to 9 months

  • Progression-free survival

    Time frame: Up to 9 months

  • Bronchial versus pulmonary artery blood supply

    Time frame: Up to 9 months

  • Lipiodol retention in treated tumors

    Time frame: 4-6 weeks post-procedure

  • Growth of TACE targeted lesions versus non-TACE targeted lesions

    Time frame: 4-6 weeks post-procedure

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

City of Hope Medical Center

Duarte, California, 91010

Recruiting
Franz E. Boas · Contact
Franz E. Boas · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Stephen B. Solomon, MD · Contact
Stephen B. Solomon, MD · Principal Investigator

References

  • Boas FE, Salgia R, Waddington T, Massarelli E, Park JJ, Kessler J, Frankel P, Alexander ES, Solomon SB. Phase II Trial of Lung Chemoembolization. J Vasc Interv Radiol. 2023 Dec;34(12):2090-2092. doi: 10.1016/j.jvir.2023.08.006. Epub 2023 Aug 21. No abstract available.(PubMed)