Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
Primary Purpose
Hepatocellular Carcinoma(HCC), Cirrhotic Portal Hypertension
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Precise hepatectomy
Combined intervention (chemoembolization/ablation)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma(HCC) focused on measuring precise hepatectomy, hepatocellular carcinoma, cirrhotic, portal hypertension, safety, combined interventional treatment
Eligibility 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
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
surgery
combined intervention
Arm Description
Precise hepatectomy
transcatheter hepatic arterial chemoembolization and/or ablation
Outcomes
Primary Outcome Measures
Overall survival
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
Treatment complication
defined as complications within the 90 days after treatment
Time to progress(TTP)
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)
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)
Quality of life: Follow the QOL-LC V2.0
Full Information
NCT ID
NCT01642446
First Posted
July 12, 2012
Last Updated
September 20, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01642446
Brief Title
Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
Official Title
A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma(HCC), Cirrhotic Portal Hypertension
Keywords
precise hepatectomy, hepatocellular carcinoma, cirrhotic, portal hypertension, safety, combined interventional treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
transartery embolization chemotherapy, infusion of Chemoembolization was performed using 30 mg/m2 of epirubicin, 200 mg/m2 of carboplatin, and 4mg/m2 of mitomycin C (MMC), mixed with 2-5 mL lipiodol. Then up to 20 mL of additional pure lipiodol was injected into the tumor-feeding artery until stasis of blood flow in the target artery was observed
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery
Arm Type
Experimental
Arm Description
Precise hepatectomy
Arm Title
combined intervention
Arm Type
Active Comparator
Arm Description
transcatheter hepatic arterial chemoembolization and/or ablation
Intervention Type
Procedure
Intervention Name(s)
Precise hepatectomy
Intervention Description
Precise hepatectomy
Intervention Type
Other
Intervention Name(s)
Combined intervention (chemoembolization/ablation)
Intervention Description
transcatheter hepatic arterial chemoembolization and/or ablation
Primary Outcome Measure Information:
Title
Overall survival
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Treatment complication
Description
defined as complications within the 90 days after treatment
Time Frame
90 days
Title
Time to progress(TTP)
Description
TTP: The Hazard Ratio will be analyzed respectively with 95% confidence interval. Meanwhile, Kaplan-Meier estimation and survival curves will be performed.
Time Frame
3 years
Title
Disease control rate(DCR)
Description
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.
Time Frame
3 years
Title
Quality of life(Qol)
Description
Quality of life: Follow the QOL-LC V2.0
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunfei Yuan
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
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Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
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