TILA-TACE in Treatment of Hepatocellular Carcinoma

NCT03910140 | Unknown DMC

• 1 other identifier: ZUSAHZUCI201701
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor Response Rate; Overall Survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lifetime (months)

  6 months once after therapy

Study Arms (1)

TILA-TACE group

EXPERIMENTAL

Procedure: TILA-TACE treatment

Interventions

TILA-TACE treatment PROCEDURE

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).

Also known as: 3D-CRT, SBRT, SIRT

TILA-TACE group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• HCC BCLC grading D;
• Child-Pugh score prior to therapy C.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy, Conformal; Sirtuins

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: April 10, 2019
• Study Start: November 1, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CN (1)