TILA-TACE in Treatment of Hepatocellular Carcinoma

Second Affiliated Hospital, School of Medicine, Zhejiang University2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Tumor Response Rate Overall Survival

Interventions

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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%.

Time frame: 1 month after therapy

Secondary Outcomes

Lifetime (months)

Record the survival time of patients by follow up visits.

Time frame: 6 months once after therapy