Clinical trial · Interventional
Phase II Trial of Lung Chemoemobolization
NCT05672108CI-TRIAL-00104740recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Endobronchial Metastases | — | UNRESOLVED | — |
| Lung Metastases From Any Primary | — | UNRESOLVED | — |
| Lung Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Mediastinal Neoplasm | Mediastinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pleural Neoplasm | Pleural Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Ethiodized Oil | Drug | — | UNRESOLVED |
| Mitomycin | Drug | Mitomycin | ALIAS |
| Transarterial Chemoembolization | Procedure | — | UNRESOLVED |
| Tris-acryl Gelatin Microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lung chemoembolization
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Drug: Ethiodized Oil
- Drug: Mitomycin
- Procedure: Transarterial Chemoembolization
- Device: Tris-acryl Gelatin Microspheres
Primary outcomes (2)
- measure
- Local progression free survival
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBoas 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. PMID 37611799