TILA-TACE in Treatment of Hepatocellular Carcinoma

Zhejiang University

Status: Enrolling

Conditions: Tumor Response Rate; Overall Survival

Treatments: Procedure: TILA-TACE treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03910140

ZUSAHZUCI201701

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

TILA-TACE group

Experimental group

Treatment:

Procedure: TILA-TACE treatment