Clinical trial · Interventional
Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
- 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)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug-eluting beads loaded with doxorubicin hydrochloride | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug-eluting bead transarterial chemoembolization (DEB-TACE)
- description
- Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.
- interventionNames
- Device: Drug-eluting beads loaded with doxorubicin hydrochloride
Primary outcomes (7)
- measure
- Safety
- timeFrame
- 1 month
- description
- Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
- measure
- Safety
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification
* No advanced disease, as defined by any of the following:
* Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:
* Vascular invasion, including segmental portal obstruction
* Extrahepatic spread
* Cancer-related symptoms (PST of 1-2)
* BCLC class D disease, as defined by the following:
* Okuda stage III disease
* World Health Organization (WHO) performance status 3 or 4
* Diffuse HCC, defined as massive ill-defined tumor involvement
* Child-Pugh Class C
* Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
* No significant liver decompensation
* Preserved liver function (Child-Pugh class A-B)
* No ascites (trace ascites allowed)
* No other active primary tumor
* Arteries supplying the lesion must be large enough to accept GelSpheres™ beads
PATIENT CHARACTERISTICS:
* Bilirubin ≤ 3 mg/dL
* Albumin \> 2.0 g/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
* No active gastrointestinal bleeding
* No encephalopathy
* No contraindication to hepatic embolization procedures, as indicated by any of the following:
* Porto-systemic shunt
* Hepatofugal blood flow
* Platelet count \< 50,000/mm\^3
* International normalized ratio (INR) ≥ 1.8
* Partial thromboplastin time (PTT) ≥ 39 seconds
* Renal failure
* Severe atheromatosis
* No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:
* Bilirubin \> 5 mg/dL
* White blood cell (WBC) \< 1,500/mm\^3
* Ejection fraction \< 50% by isotopic ventriculography or echocardiography
* Not pregnant
* No known allergy to contrast media
* No intolerance to occlusion procedures
* No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:
* Active or risk of hemorrhage
* Patent extra-to-intracranial anastomoses or shunts
* End arteries leading directly to the cranial nerves
* Feeding arteries smaller than distal branches from which they emerge
* Collateral vessel pathways that would potentially endanger normal territories during embolization
PRIOR CONCURRENT THERAPY:
* No prior anticancer therapy for HCCReferences
Publications (1)
- RESULTReyes DK, Vossen JA, Kamel IR, Azad NS, Wahlin TA, Torbenson MS, Choti MA, Geschwind JF. Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States. Cancer J. 2009 Nov-Dec;15(6):526-32. doi: 10.1097/PPO.0b013e3181c5214b. PMID 20010173