Clinical trial · Interventional
Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC
Sorafenib Plus Transarterial Chemoembolization Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced Hepatocellular Carcinoma: A Phase 3, Multicenter, Randomized Controlled Trial
- 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 trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.
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 |
| Transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. If any drug related adverse event occurred, the dosage will be reduced.
- interventionNames
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- Sorafenib plus TACE
- description
- Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. TACE will be performed on the fourth day after randomization. If any drug related adverse event occurred, the dosage will be reduced.
- interventionNames
- Drug: Sorafenib
- Procedure: Transarterial chemoembolization
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary hepatocellular carcinoma without any treatments. 2. Received curative hepatic resection 3. ECOG score 0-1 4. Child-Pugh grade A 5. Sufficient liver and kidney function Exclusion Criteria: 1. Diffused lesions; tumor thrombosis in SMV or IVC. 2. Extra-hepatic metastasis. 3. Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc. 4. Allergic to the contrast agent of TACE 5. Dysfunction of liver, kidney or bone marrow. 6. Concomitant other malignant tumor or HIV infection
References
Publications (1)
- DERIVEDPeng Z, Fan W, Liu Z, Xiao H, Wu J, Tang R, Tu J, Qiao L, Huang F, Xie W, Zhuang W, Guo W, Li S, Hua Y, Shen S, He Q, Li D, Li J, Kuang M. Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus: A Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):616-624. doi: 10.1001/jamasurg.2024.0506. PMID 38568599