TILA-TACE in Treatment of Hepatocellular Carcinoma

Not Applicable

• Conditions: Tumor Response Rate; Overall Survival
• Interventions: Procedure: TILA-TACE treatment

• Registration Number: NCT03910140
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2019-02-18
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-08
• Last Update Submitted: 2019-04-08
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TILA-TACE group	TILA-TACE treatment	-

Primary Outcome Measures

Name	Time	Method
The response to treatment	1 month after therapy	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%.

Secondary Outcome Measures

Name	Time	Method
Lifetime (months)	6 months once after therapy	Record the survival time of patients by follow up visits.

Trial Locations

Locations (1)

The Second affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China