Clinical trial · Interventional
DEB-TACE+HAIC vs. HAIC for Large HCC
Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma
NCT05263219CI-TRIAL-00067408unknownPhase 3ClinicalTrials.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 study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone 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 |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dTACE-HAIC | Procedure | — | UNRESOLVED |
| dTACE-HAIC protocol | Drug | — | UNRESOLVED |
| HAIC | Procedure | — | UNRESOLVED |
| HAIC protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy
- description
- Patients will receive the combination treatment of DEB-TACE and HAIC.
- interventionNames
- Procedure: dTACE-HAIC
- Drug: dTACE-HAIC protocol
- type
- ACTIVE_COMPARATOR
- label
- Hepatic arterial infusion chemotherapy
- description
- Patients will receive HAIC treatment alone.
- interventionNames
- Procedure: HAIC
- Drug: HAIC protocol
Primary outcomes (1)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with HCC confirmed by histology/cytology or diagnosed clinically. * The maximum HCC lesion \> 7 cm. * Unresectable HCC evaluated by the surgeon team. * At least one measurable intrahepatic target lesion. * Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A. * ECOG score of performance status ≤ 1 point. * Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range. * Life expectancy of at least 3 months. Exclusion Criteria: * Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein. * Accompanied with vena cava tumor thrombus. * Extrahepatic metastasis. * Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy. * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy. * Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment. * History of other malignancies. * Uncontrollable infection. * History of HIV. * Allergic to the drugs involved in the research. * Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3. * History of organ or cells transplantation. * Those with bleeding tendency.
References
Publications (0)
Data not yet available
No reference posted for this study.