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

This study is currently recruiting participants.
Verified October 2016 by Yunfei Yuan, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642446
First Posted: July 17, 2012
Last Update Posted: October 17, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yunfei Yuan, Sun Yat-sen University
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma(HCC) Cirrhotic Portal Hypertension Procedure: Precise hepatectomy Other: Combined intervention (chemoembolization/ablation) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension

Further study details as provided by Yunfei Yuan, Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ]
    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


Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ]
    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 ]
    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 ]
    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 ]
    Quality of life: Follow the QOL-LC V2.0


Estimated Enrollment: 360
Study Start Date: January 2013
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery
Precise hepatectomy
Procedure: Precise hepatectomy
Precise hepatectomy
Active Comparator: combined intervention
transcatheter hepatic arterial chemoembolization and/or ablation
Other: Combined intervention (chemoembolization/ablation)
transcatheter hepatic arterial chemoembolization and/or ablation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01642446


Contacts
Contact: Yunfei Yuan, MD 86-20-87343118 yuanyf@mail.sysu.edu.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Yunfei Yuan         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Yunfei Yuan Sun Yat-sen University
  More Information

Responsible Party: Yunfei Yuan, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01642446     History of Changes
Other Study ID Numbers: 20125010Y
First Submitted: July 12, 2012
First Posted: July 17, 2012
Last Update Posted: October 17, 2016
Last Verified: October 2016

Keywords provided by Yunfei Yuan, Sun Yat-sen University:
precise hepatectomy
hepatocellular carcinoma
cirrhotic
portal hypertension
safety
combined interventional treatment

Additional relevant MeSH terms:
Carcinoma
Hypertension
Carcinoma, Hepatocellular
Hypertension, Portal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases