Clinical trial · Observational
The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
- 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)
Transarterial chemoembolization (TACE) is widely applied and shows good efficacy in advanced hepatocellular carcinoma (HCC). Recently, hepatic arterial infusion chemotherapy (HAIC) has also gained popularity in the treatment of HCC. Several studies have described the comparison between HAIC and TACE or TACE combined with HAIC. However, the evaluation between TACE plus HAIC and HAIC is rarely reported. Here, we will evaluate the performance of HepaSphere DEB-TACE combined with HAIC (HEPA-HAIC) comparing to HAIC in patients with advanced 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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE plus HAIC or HAIC alone | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HEPA-HAIC group
- description
- HEPA-HAIC group is composed of advanced HCC patients treated with HepaSphere DEB-TACE combined with HAIC as the interventional therapy
- interventionNames
- Procedure: DEB-TACE plus HAIC or HAIC alone
- label
- HAIC group
- description
- HAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy
- interventionNames
- Procedure: DEB-TACE plus HAIC or HAIC alone
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 3 year
- description
- Progression-free survival is defined as the time from the start of treatment DEB-TACE plus HAIC or HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: ≥18 years old * Gender: no limitation * Diagnosed as primary hepatocellular carcinoma histologically or clinically * Imaging data within 31 days at enrollment and at least one measurable lesion (according to mRECIST criteria) is available * Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) or HAIC alone during the observation period * Child-Pugh: A-B * ECOG: 0-2. Exclusion Criteria: * Other cancer diseases are co-existed * Drug-eluting beads from other manufacturers were used during DEB-TACE * DEB-TACE combined with HAIC or HAIC alone was used as postoperative adjuvant therapy * Pre- or post-surgery relevant examination results were unavailable * Imaging information for effectiveness evaluation was unavailable * Follow-up failure due to patient information errors, loss, refusal, etc
References
Publications (0)
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