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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
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This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE) simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half participants will receive TAE simultaneously combined with thermal ablation and the other half receive TACE sequentially combined with thermal ablation, which is a conventional treatment for HCC patients.
The treatment method "Transarterial chemoembolization (TACE) sequentially combined with thermal ablation" is recommend for large HCC patients from NCCN Guideline and Chinese guideline "Diagnosis and Treatment of Primary Liver Cancer". The details of this sequential method consist one or more times of TACE followed by thermal ablation at least one month later to make the tumor completely inactivate. The thermal ablations include multiple applicators radiofrequency or microwave ablations. However, this method includes such disadvantages. 1) The limitation of lipiodol dosage in one TACE session is 30ml so that many patients needs more sessions of TACE; (2) Lipiodol and chemical drugs is easy to leak when patients have hepatic arteriovenous fistula. (3) Repeated TACE could cause more serious side effects. (4) Tumors of many patients are still not controlled or grow too large to ablate after TACEs which increases the metastasis risk and affects the efficacy and survival time.
However, TAE simultaneously combined with thermal ablation is another combination type which reduce the interval time between two procedures from one month to 1-3 days. TAE removes the chemical drugs and uses embolic agents such as Embosphere to obstruct vessels to enhance the effect of followed ablations. The main aim of reducing interval and remove chemical drugs is to make the tumor completely inactivate in one hospitalization like surgical operation, hoping bringing less side effects, better efficacy and longer survival time.
Thus the investigators will launch a prospective, multicenter randomized controlled clinical trial to compare the 3-years overall survival, safety, social and economic benefit of TAE simultaneously combined with ablation and TACE sequentially combined with ablation. The investigators expect to acquire Ia-level evidence-based medical evidence which can be accepted by the clinical guideline, popularizing, demonstrating our therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAE combined ablation simultaneously | Experimental | TAE simultaneously combined with ablation.The treatment interval is 1-3 days between two procedures. TAE using embolic agents(Lipiodol/Gelatin sponge/PVA particles(300~500μm)/Blank microspheres). |
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| TACE combined ablation sequentially | Other | TACE sequentially combined thermal ablation.The treatment interval is 1 month between two procedures. TACE using chemotherapy drug(Doxorubicin/platinum agents) and embolic agents(Lipiodol/Gelatin sponge/PVA particles(300~500μm)/Blank microspheres). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy drug | Drug | Doxorubicin/Platinum agents |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From complete remission of the index large tumor to patient death or the completion of this trial | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival | From complete remission of the index large tumor to tumor recurrence either in- or extra- hepatic or the completion of this trial | 3 years |
| liver and renal function | Alanine aminotransferase,Ast,total bilirubin,albumin,creatinine,Urea nitrogen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinhua Huang, Ph.D | Contact | 0086-20-87343272 | huangjh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jinhua Huang, Ph.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
| D060205 | Therapeutic Occlusion |
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| Sixth Affiliated Hospital, Sun Yat-sen University |
| OTHER |
| Guangdong Provincial People's Hospital | OTHER |
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| Embolic agents | Drug | Lipiodol/Gelatin sponge/PVA/Blank microspheres |
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| Simultaneously | Procedure | 1-3 days |
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| Sequentially | Procedure | 1 month |
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| Ablation | Device | Radiofrequency ablation/Microwave ablation |
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| 3 years |
| Complications | number of participants with Complications | 3 years |
| Times of interventional procedures | The number of procedures for each patient, either TACE/TAE or ablation | 3 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |