Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
| Registry | NCT01393197, acronym TACE-KMG |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: double, treatment |
| Enrollment | 2480 (Estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital (Other) |
| Conditions | Carcinoma, Hepatocellular |
| Interventions | Therapeutic Chemoembolization (Other) |
| Dates | start 2011-03-01, primary completion 2016-11-01 (estimated), completion 2016-12-01 (estimated), first posted 2011-07-13, last updated 2015-12-18 |
| Locations | 1 site in China |
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The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?
The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TACE -oil | Active comparator | Other: Therapeutic Chemoembolization | embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge |
| TACE-KMG ( routine dose Chemo) | Experimental | Other: Therapeutic Chemoembolization | embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2） |
| TACE-KMG( low dose Chemo ) | Experimental | Other: Therapeutic Chemoembolization | embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2） |
| TACE-KMG(without chemo) | Experimental | Other: Therapeutic Chemoembolization | embolization agent:KMG microsphere( 150-450µm,0.2-2g) |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention * liver function:Child-Pugh A、B * PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG） * Lifespan≥6 months * First time to receive treatment * Can accept the follow up * informed consent was gotten * the number of lesion ≤ 5 Exclusion Criteria: * pregnant or lactation woman * emotional disturbance * serious heart ,lung disfunction or serious diabetes mellitus * serious reactiveness infections;（exp:type B or C hepatitis） * liver function :Child-Pugh Score C * thrombocyte<6×109/L * diffuse HCC * widespread metastasis * serious atherosclerosis * acquired immunodeficiency syndrome;AIDS * thrombosis or thrombosis event in 6 months * renal inadequacy who need hemodialysis or peritoneal dialysis * with other tumors except basal cell carcinoma and carcinoma in situ of cervix * serious alimentary tract hemorrhage in 4 weeks
| Facility | City | Country | Status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin, Tianjin Municipality | China | Recruiting |