TILA-TACE in Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.

Official Title
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A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma

Conditions
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Tumor Response Rate, Overall Survival

Intervention / Treatment
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* Procedure: TILA-TACE treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard; ECOG score 0-1; HCC BCLC grading 0, A, B, C; Child-Pugh score prior to therapy A and B; As judged by investigators, the patient can comply with the study protocol; Patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form. Exclusion Criteria: HCC BCLC grading D; Child-Pugh score prior to therapy C.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TILA-TACE group<br> | Procedure: TILA-TACE treatment<br>* TACE was performed through the transfemoral route using a 5-Fr catheter (Shepherd-hook modified Angiographic Catheter, HANACO Medical, Tian Jin, China ) that was advanced from celiac artery to common hepatic artery, proper hepatic artery, hepatic artery and ultimately to tumor feeding arteries which are defined by angiography. Then, a coaxial microcatheter (2.8 Fr Marguerite II, ASAHI INTECC GMA CO., LTD, Nagoya, Japan) was selectively inserted through a 5-Fr catheter into the tumor feeding artery, into which, 5% sodium bicarbonate was infused alternatively with doxorubicin-lipiodol emulsion. Finally, the artery was embolized with PVA (Embosphere®, BioSphere Medical, Paris, France) and microcoil ( Tornado ®, COOK Medical, USA).<br>* Other names: SIRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response to treatment | Viable tumors were assessed by MRI according to EASL criteria. The enhanced and non-enhanced areas represent viable and necrotic tumors. At least 2 radiologists evaluate the approximate viable tumor residues (%) of total tumor volume (Total tumor volume was the sum of viable and necrotic volume). The response to treatment is defined by the Viable Tumor Residues (%) as below: complete response (CR), no obvious viable residuals; near complete response (NCR), viable residuals <10%; partial response (PR), viable residuals >10% but < 50%; stable disease (SD), viable tumor residuals between >50% but ≤100%; and progressive disease (PD), viable tumors > 100%. | 1 month after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifetime (months) | Record the survival time of patients by follow up visits. | 6 months once after therapy |