Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

Carcinoma, Hepatocellular Clinical Trial

Official title:

The Guiding Value of Tumor Micronecrosis for Using Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352204
• Other study ID #: PTHCC
• Status: Completed
• Start date: April 30, 2020
• Est. completion date: April 14, 2022

Study information

• Verified date: February 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: April 14, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (1) pathologically confirmed HCC (2) achievement of R0 resection.

Exclusion Criteria:

• (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• transcatheter arterial chemoembolization
transcatheter arterial chemoembolization after liver resection

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	the First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	the number of months from the date of surgery to the date of the last follow-up visit or time of death.	after liver resection until June 1, 2020
Secondary	disease-free survival	the number of months from the date of surgery to the date of first confirmable recurrence or death	after liver resection until June 1, 2020