Prognostic Models for HCC Based on Tumor Micronecrosis

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: observing whether HCC patients having tumor micronecrosis

• Registration Number: NCT05837065
• Lead Sponsor: Zhejiang University

Brief Summary

The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Primary Completion: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-27
• Last Update Submitted: 2023-04-27
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 765

Inclusion Criteria

1. pathologically diagnosed as HCC;
2. curative hepatectomy with R0 resection;
3. conserved liver function with Child Pugh class A or B

Exclusion Criteria

1. with macrovascular invasion or extrahepatic metastasis;
2. receiving other anti-tumor treatments such as TACE or systemic drugs;
3. with other primary cancers;
4. incomplete follow-up data;
5. without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
validation cohort	observing whether HCC patients having tumor micronecrosis	HCC patients receiving curative hepatic resection
training cohort	observing whether HCC patients having tumor micronecrosis	HCC patients receiving curative hepatic resection

Primary Outcome Measures

Name	Time	Method
the Harrell concordance index (C-index)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
the time-dependent area under the receiver operating characteristic curve(tdAUROC)	Up to 5 years

Trial Locations

Locations (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China