Clinical trial · Interventional
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion
Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion
NCT01901692CI-TRIAL-00029581STARTcompletedPhase 2 / Phase 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)
To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels
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+External beam RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE+External beam RT
- description
- Transarterial chemoembolization plus external beam radiation therapy
- interventionNames
- Radiation: TACE+External beam RT
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Sorafenib 800 mg/day orally
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Progression-free survival (PFS) rate
- timeFrame
- at 12 weeks after randomization
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>19 years * Child-Pugh class A liver function * Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1 * Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy * HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava * Reserved unilateral portal blood flow at least in partial * HCC size larger than 1 cm and less than 50% of total liver volume * No confirmed extrahepatic metastasis * Adequate hematopoietic function Hemoglobin ≥ 8.5 g/dL Absolute neutrophil count ≥ 750/mm3 Platelet count ≥ 30,000/mm3 * Creatinine \< 1.5mg/dL * No plan for pregnancy or breast feeding. Active contraception. * Willing to give informed consent Exclusion Criteria: * Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib * Complete obstruction of hepatic outflow * Confirmed extrahepatic metastasis of HCC * HCC occupying more than 50% of liver volume * Uncontrolled ascites of hepatic encephalopathy * Prior liver transplantation * Positive for human immunodeficiency virus (HIV) * Active gastric or duodenal ulcer * Other uncontrolled comorbidities or malignancy * Inability to give informed consent
References
Publications (1)
- DERIVEDYoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847. PMID 29543938