Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Yunfei Yuan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01642446
First received: July 12, 2012
Last updated: May 13, 2013
Last verified: May 2013

July 12, 2012
May 13, 2013
January 2013
June 2022   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Overall survival is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse
Same as current
Complete list of historical versions of study NCT01642446 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Safety:Including adverse events and abnormal laboratory test, incidence, severity, time of occurrence, severity and correlation. Evaluation according to NCI-CTC 3.0.
  • Time to progress(TTP) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    TTP: The Hazard Ratio will be analyzed respectively with 95% confidence interval. Meanwhile, Kaplan-Meier estimation and survival curves will be performed.
  • Disease control rate(DCR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Disease control rate: Calculate the disease control rate of the two treatment groups (disease control rate) and its 95% confidence interval, and make a descriptive analysis.
  • Quality of life(Qol) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Quality of life: Follow the QOL-LC V2.0
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Safety:Including adverse events and abnormal laboratory test, incidence, severity, time of occurrence, severity and correlation. Evaluation according to NCI-CTC 3.0.
  • Time to progress(TTP) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    TTP: The Hazard Ratio will be analyzed respectively with 95% confidence interval. Meanwhile, Kaplan-Meier estimatation and survival curves will be performed.
  • Disease control rate(DCR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Disease control rate: Calculate the disease control rate of the two treatment groups (disease control rate) and its 95% confidence interval, and make a descriptive analysis.
  • Quality of life(Qol) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Quality of life: Follow the QOL-LC V2.0
Not Provided
Not Provided
 
Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension

There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, While this group of patients are classified as hepatectomy contraindication according to guidelines from National Comprehensive Cancer Network (NCCN) and American Association for the Study of Liver Diseases (AASLD). With improvement of surgical technique, preoperative evaluation, and perioperative management,especially the Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal hypertension.However, most of the previous studies were either retrospective or with small samples.

The investigators project is a prospective randomized controlled trial, planning to compare the safety, efficacy and quality of life between precise hepatectomy and combined interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, to make a further understanding of optimal strategy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatocellular Carcinoma(HCC)
  • Cirrhotic Portal Hypertension
  • Procedure: Precise hepatectomy
    Precise hepatectomy
  • Other: Combined intervention (chemoembolization/ablation)
    transcatheter hepatic arterial chemoembolization and/or ablation
  • Experimental: surgery
    Precise hepatectomy
    Intervention: Procedure: Precise hepatectomy
  • Active Comparator: combined intervention
    transcatheter hepatic arterial chemoembolization and/or ablation
    Intervention: Other: Combined intervention (chemoembolization/ablation)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
June 2022
June 2022   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma patients, in accordance with HCC Professional Committee of the Chinese Anti-Cancer Association 2001 "Clinical Diagnosis of Primary Liver Cancer and Staging Criteria"
  • solitary tumor ≤5cm, or three or fewer lesions none ≤3cm,As Milan criteria
  • History of hepatitis B or HBsAg positive
  • Cirrhosis and portal hypertension
  • No treatment on liver cancer before
  • KPS score ≥ 70
  • The age of 18 to 65 years
  • Child-Pugh A or B (Class B, scoring no more than 7 points)
  • Baseline laboratory test comply with the following criteria:

    • White blood cell ≥ 1.0×109/L
    • Platelet ≥ 25×109/L
    • Hemoglobin ≥ 80g/L
    • Serum ALT,AST ≤ 3×upper limit of normal (ULN)
    • Serum creatinine ≤ 1.5 × ULN
    • INR<1.5, or prothrombin time <ULN +4 sec
    • Albumin ≥30g/L
    • Total bilirubin ≤34mmol/L
  • Informed consent with signature and time
  • Good patient compliance
  • The surgical group patients received radical hepatectomy. Radical surgery is defined as: complete resection of visible tumor, R0 resection margins, and also including:

    • The number of tumors is less than 3
    • No tumor thrombus found in major branch of the portal veins, hepatics, inferior vena cava or bile duct
    • No hepatic hilar lymph node metastasis
    • No extrahepatic metastasis

Exclusion Criteria:

  • extrahepatic metastasis; With metastasis in major branch of portal vein, hepatic vein
  • History of hepatitis C or HCV-Ab positive
  • Pugh Child-Pugh C, or with massive ascites or had a history of hepatic encephalopathy, or Upper digestive tract bleeding
  • Poor physical condition or cachexia
  • During the past 12 months just before the study, there had been any of the following: myocardial infarction, severe/unstable angina, coronary artery bypass graft surgery, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; arrhythmia according to the NCI-CTCAE ≥ grade 2, QTc interval extension (male> 450 ms, female> 470 ms);
  • Renal insufficiency, need peritoneal dialysis or hemodialysis
  • Serious dysfunction of other organs
  • History of second primary malignant tumors
  • Known or new evidence of brain or leptomeningeal disease
  • Hemophilia or bleeding tendency, and are taking therapeutic doses of coumarin derivative anticoagulant therapy drugs
  • Pregnant or lactation, all female patients with childbearing potential must have a pregnancy test (serum or urine) within 7 days after enrollment,and the result is negative
  • History of organ transplantation
  • Known HIV infection
  • With any other serious acute and chronic physical or mental disease or abnormal laboratory tests, which are likely to increase risks or interfere with the interpretation of the results, or researchers believe that patients are not suitable for enrollment
Both
18 Years to 65 Years
No
Contact: Yunfei Yuan, MD 86-20-87343118 yuanyf@mail.sysu.edu.cn
China
 
NCT01642446
20125010Y
Yes
Yunfei Yuan, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Yunfei Yuan Sun Yat-sen University
Sun Yat-sen University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP