A Simple Prognostic Scoring System for Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT02061956
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most frequent cause of death of cancer.Although with the development of medical science, more and more patients diagnose HCC at early stage, a lot of patients with HCC still continue to present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these patients could received transcatheter arterial chemoembolization (TACE) or new agents as initial treatment. However, the intermediate group comprises a wide spectrum in terms of liver function and extent of tumour, and this may explain the large differences in survival reported for individual series.

A simple, pragmatic and reliable prognostic index based on objective measures would be of value in providing information to patients, for stratifying patients entering clinical trials and in making meaningful comparisons between series reported in the literature.The aims of our study were (i) to identify predictors of survival in a cohort of patients undergoing TACE or TAE for unresectable HCC, (ii) to develop and validate a simple scoring system and (iii) to compare the new scoring system with the most frequently used prognostic systems for its ability to separate high- and low-risk patients.

Detailed Description

Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most frequent cause of death of cancer. The 2005 guidelines of the American Association for the Study of Liver Diseases (AASLD) for HCC states that hepatic resection(HR) can be offered to patients with a solitary lesion if they are non-cirrhotic, or have cirrhosis but still have well-preserved liver function. With the improvement of surgical technique and perioperative care, the surgical mortality for HCC resection can be reduced to less than 1%, and the 5-year overall survival can exceed 50%. Although with the development of medical science, more and more patients diagnose HCC at early stage, a lot of patients with HCC still continue to present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these patients could received transcatheter arterial chemoembolization (TACE) or new agents as initial treatment. However, the intermediate group comprises a wide spectrum in terms of liver function and extent of tumour, and this may explain the large differences in survival reported for individual series.

A simple, pragmatic and reliable prognostic index based on objective measures would be of value in providing information to patients, for stratifying patients entering clinical trials and in making meaningful comparisons between series reported in the literature.The aims of our study were (i) to identify predictors of survival in a cohort of patients undergoing TACE or TAE for unresectable HCC, (ii) to develop and validate a simple scoring system and (iii) to compare the new scoring system with the most frequently used prognostic systems for its ability to separate high- and low-risk patients.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2014-01-22
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-13
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 647

Inclusion Criteria

1. age between 18-75 years;
2. Child-Pugh A or B liver function;
3. Eastern Cooperative Oncology Group (ECOG) performance scores ≤2;
4. HCC with no previous treatment;

Exclusion Criteria

1. severe coagulopathy (prothrombin activity <40% or a platelet count of <40,000/mm3);
2. Child-Pugh C liver function or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy;

(4) ECOG scores 3-4 (5) combined with serious diseases of other organs.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy	1 year	1-year overall survival

Secondary Outcome Measures

Name	Time	Method
Safety	1 month	1 month mortality

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China