Carcinoma, Hepatocellular, Survival Rate
Conditions
Keywords
Hepatocellular Carcinoma, Hepatic Resection, TACE, Solitary Huge Tumor, Overall Survival
Brief summary
This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.
Interventions
PROCEDUREhepatic resection
The aim of this intervention is to reach curative resection.
PROCEDURETACE
The aim of this intervention is one of the palliative treatment.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Hepatic cellular Carcinoma. * Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI. * Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis. * Patients without surgical contraindication. * Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment. * Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, blood platelet counts (PLT) \> 8×10\*10/L before treatment. * Patients without severe esophagogastric varices before treatment. * Patients with HBV，HBV DNA≤100, 000 copy/mL. * All of the patients has written consent for this research.
Exclusion criteria
* Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. * Patients with surgical contraindication. * Patients with Child C grade liver function before treatment. * Patients with other malignancy. * .Patients treated with hepatic resection or TACE before this treatment. * Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival | 3 years | Overall survival rate will be evaluated at 3 years after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year overall survival | 1 years | Overall survival rate will be evaluated at 1 year after treatment |
| 2-year overall survival | 2 years | Overall survival rate will be evaluated at 2 years after treatment |
| Recurrence rates | 3 years | any recurrence detected by CT, MRI and laboratory examination |
Other
| Measure | Time frame | Description |
|---|---|---|
| mortality | 30 days | death within 30 days after surgery |
Countries
China
Contacts
Primary ContactGanxun Li, Doctor
Backup ContactXiaoping Chen, Doctor
Outcome results
None listed