Clinical trial · Interventional
DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study
- 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 study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).
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 |
|---|---|---|---|
| Hepatocellular Carcinoma Non-resectable | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional transarterial chemoembolization (cTACE) | Procedure | — | UNRESOLVED |
| Drug-eluting bead transarterial chemoembolization (DEB-TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DEB-TACE
- description
- DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment.
- interventionNames
- Procedure: Drug-eluting bead transarterial chemoembolization (DEB-TACE)
- type
- ACTIVE_COMPARATOR
- label
- cTACE
- description
- cTACE will be performed for the patients who choose cTACE as the primary treatment.
- interventionNames
- Procedure: Conventional transarterial chemoembolization (cTACE)
Primary outcomes (1)
- measure
- Success rate of conversion to resection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically. 2. The tumor lesion was only localized in one liver lobe. 3. Large HCC with single lesion \> 7 cm, or multiple lesions. 4. unresectable HCC evaluated by the surgeon team. 5. The patient is suitable for TACE treatment, which is evaluated by MDT. 6. At least one measurable intrahepatic target lesion. 7. Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A. 8. ECOG score of performance status ≤ 1 point. 9. Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils \>1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range. 10. Patients have the willingness to receive TACE as the conversion therapy for surgical resection. Exclusion Criteria: 1. Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein. 2. Accompanied with hepatic vein and vena cava tumor thrombus. 3. The extent of the lesion exceeds one liver lobe or extrahepatic metastasis. 4. Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy. 5. Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy. 6. History of other malignancies. 7. Uncontrollable infection. 8. Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA \<10\^3 IU/mL. 9. HCV patients need to complete the anti-HCV therapy before they are enrolled. 10. History of HIV. 11. Allergic to the drugs involved in the research. 12. Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3. 13. History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy 14. Those with bleeding tendency.
References
Publications (0)
Data not yet available