Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02061956
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Chen Min-Shan, 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.


Condition or disease
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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 647 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Simple Prognostic Scoring System for Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 1 year ]
    1-year overall survival


Secondary Outcome Measures :
  1. Safety [ Time Frame: 1 month ]
    1 month mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061956


Locations
Layout table for location information
China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University

Layout table for additonal information
Responsible Party: Chen Min-Shan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02061956     History of Changes
Other Study ID Numbers: HCC-0014
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases