Clinical trial · Interventional
Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants were enrolled
Summary
Brief summary (as posted)
The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The TACE/TACI combination group
- description
- Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination
- interventionNames
- Drug: Doxorubicin
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- The TACE-only group
- description
- Transarterial chemoembolization with doxorubicin
- interventionNames
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- every 12 weeks, up to 48 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC * Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI * Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible * Age : 18 years to 80 years * ECOG Performance Status of 0 to 2 * Child-Pugh class A (Child-Pugh score 5-6) * Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * WBC count \> 2,000/mm3 * Absolute neutrophil count \> 1,000/mm3 * Hb ≧ 8.0 g/dL * Platelet count ≧ 50,000 /mm3 * Bilirubin ≦ 3 mg/dL * Adequate clotting function: INR \< 2.3 or \< 6sec Exclusion Criteria: * Child-Pugh score ≧ 7 * ECOG Performance Status ≧ 3 * Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL * History of organ allograft * Patients with uncontrolled co-morbidity which needs treatment * Patients who have received prior systemic chemotherapy * Patients with extrahepatic metastasis
References
Publications (0)
Data not yet available