Clinical trial · Interventional
Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor
Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial
NCT03191123CI-TRIAL-00032510unknownN/AClinicalTrials.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)
This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Survival Rate | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatic resection | Procedure | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hepatic resection
- description
- Indications for Hepatic resection were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.
- interventionNames
- Procedure: hepatic resection
- type
- EXPERIMENTAL
- label
- Transarterial Chemoembolization(TACE)
- description
- Transarterial Chemoembolization is performed in less than one week after clinical diagnosis.
- interventionNames
- Procedure: TACE
Primary outcomes (1)
- measure
- 3-year overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of Hepatic cellular Carcinoma. * Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI. * Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis. * Patients without surgical contraindication. * Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment. * Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, blood platelet counts (PLT) \> 8×10\*10/L before treatment. * Patients without severe esophagogastric varices before treatment. * Patients with HBV，HBV DNA≤100, 000 copy/mL. * All of the patients has written consent for this research. Exclusion Criteria: * Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. * Patients with surgical contraindication. * Patients with Child C grade liver function before treatment. * Patients with other malignancy. * .Patients treated with hepatic resection or TACE before this treatment. * Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.
References
Publications (3)
- RESULTYin L, Li H, Li AJ, Lau WY, Pan ZY, Lai EC, Wu MC, Zhou WP. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan Criteria: a RCT. J Hepatol. 2014 Jul;61(1):82-8. doi: 10.1016/j.jhep.2014.03.012. Epub 2014 Mar 17. PMID 24650695
- RESULTMetussin A, Patanwala I, Cross TJ. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan criteria: a RCT. J Hepatol. 2015 Mar;62(3):747-8. doi: 10.1016/j.jhep.2014.08.057. Epub 2014 Nov 7. No abstract available. PMID 25450210
- RESULTJin YJ, Lee JW, Choi YJ, Chung HJ, Kim YS, Lee KY, Ahn SI, Shin WY, Cho SG, Jeon YS. Surgery versus transarterial chemoembolization for solitary large hepatocellular carcinoma of BCLC stage A. J Gastrointest Surg. 2014 Mar;18(3):555-61. doi: 10.1007/s11605-013-2440-x. Epub 2014 Jan 14. PMID 24420729