Clinical trial · Interventional
TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma
TRansarterial ChEmoembolization Plus SorAfenib Versus Transarterial Chemoembolization Alone for Recurrent Intermediate Hepatocellular Carcinoma: A Phase 3, Open Label, Multicenter, Randomized Controlled Trial
NCT04103398CI-TRIAL-00074480TREATcompletedPhase 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)
The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.
Conditions
Conditions (3)
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 |
| Sorafenib | — | UNRESOLVED | — |
| Transarterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Procedure | — | UNRESOLVED |
| TACE+sorafenib | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transarterial chemoembolization combined with sorafenib
- description
- The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.
- interventionNames
- Combination Product: TACE+sorafenib
- type
- ACTIVE_COMPARATOR
- label
- Transarterial chemoembolization alone
- description
- Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (oxaliplatin 200mg, raltitrexed 4mg, epirubicin 20mg in cTACE or 70mg in dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.
- interventionNames
- Procedure: TACE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-75 years; 2. Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis; 3. Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion \>3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion; 4. Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor; 5. Eastern Cooperative Oncology Group scoring 0-1; 6. Child-Pugh A class; 7. At least 3 months of life expectancy; 8. Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10\^9/L, platelet ≥ 60 x10\^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT \< 5×ULN, AST \< 5×ULN, alkaline phosphatase \< 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine\<1.5×ULN. Exclusion Criteria: 1. Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden\>50%; 2. Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice; 3. Have contraindications for TACE; 4. Have metastasis in central nervous system; 5. Allergic to intravenous contrast agents; 6. Pregnant or breastfeeding women, or expecting to conceive or father children within two years; 7. Infection of HIV, known syphilis requiring treatment; 8. Have a known history of prior invasive malignancies within 5 years before enrolment; 9. Patients with allotransplantation; 10. Severe dysfunction involving heart, kidney or other organs; 11. Severe active clinical infection which is over grade 2 based on NCI-CTC version 4; 12. Patients with mental disorders which may impact informed consent; 13. Unable to orally take drugs; 14. Participating other clinical drug trials 12 months before enrolment.
References
Publications (1)
- DERIVEDFan W, Zhu B, Chen S, Wu Y, Zhao X, Qiao L, Huang Z, Tang R, Chen J, Lau WY, Chen M, Li J, Kuang M, Peng Z. Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma: Sorafenib Plus TACE vs TACE Alone Randomized Clinical Trial. JAMA Oncol. 2024 Aug 1;10(8):1047-1054. doi: 10.1001/jamaoncol.2024.1831. PMID 38900435