TILA-TACE in Treatment of Hepatocellular Carcinoma

Overall Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910140
• Other study ID #: ZUSAHZUCI201701
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Overall Survival
• Tumor Response Rate

Intervention

Procedure:
• TILA-TACE treatment
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).

Locations

Country	Name	City	State
China	The Second affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lifetime (months)	Record the survival time of patients by follow up visits.	6 months once after therapy