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A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma(HCC), Cirrhotic Portal Hypertension

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Trial Information

A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome 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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Yunfei Yuan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

20125010Y

NCT ID:

NCT01642446

Start Date:

January 2013

Completion Date:

June 2022

Related Keywords:

  • Hepatocellular Carcinoma(HCC)
  • Cirrhotic Portal Hypertension
  • precise hepatectomy
  • hepatocellular carcinoma
  • cirrhotic
  • portal hypertension
  • safety
  • combined interventional treatment
  • Carcinoma
  • Hypertension
  • Hypertension, Portal
  • Carcinoma, Hepatocellular

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