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

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma

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 Type: Observational
• Enrollment (Actual): 647

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Cancer Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with unresectable HCC received TACE.The diagnosis of HCC was confirmed by either histology, cytology, elevated alpha-fetoprotein (AFP, >400 ng/mL), or by typical radiological appearance.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HCC received TACE; Patients with HCC in cancer center, Sun Yat-sen University received TACE between 2011.01-2011.12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	1-year overall survival	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	1 month mortality	1 month

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: HCC-0014