Clinical trial · Interventional
Sorafenib VS TACE in HCC Patients With Portal Vein Invasion
An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
NCT01480817CI-TRIAL-00021969terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty of participant enrollment.
Summary
Brief summary (as posted)
The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of 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 |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
| TACE for HCC with portal vein invasion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Sorafenib 400mg po bid
- interventionNames
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- TACE for HCC with portal vein invasion
- description
- Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents.
- interventionNames
- Procedure: TACE for HCC with portal vein invasion
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. 80 \> Age \>= 18 years. 2. Child-Pugh class A (class B could be included when Childs score is 7). 3. Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI * not only newly diagnosed treatment-naive patients, * but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion 4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: * White blood cell counts (WBC) \>= 2,000 /μl, Absolute neutrophil count (ANC) \> 1,200/μl * Hemoglobin \>= 8.0 g/dl * Platelet count \> 50,000/μl * Serum creatinine \< 1.7 mg/dl * Total bilirubin =\< 3.0 mg/dl * Prothrombin Time (PT)-international normalized ratio (INR) =\< 2.3 or Prothrombin Time (PT)-sec =\< 6 sec 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. Exclusion Criteria: 1. Child-Pugh score \>= 8. 2. Age \< 18 or \>= 80 years. 3. ECOG Performance Status \>= 3. 4. Recipient of living donor or deceased donor liver transplantation 5. Patients unable to understand the contents of informed consent or refuse to sign the informed consent. 6. Patients with evidence of uncontrolled or severe medical conditions requiring treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.