Clinical trial NCT03191123: Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor
Official title: Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Survival Rate
Keywords: Hepatocellular Carcinoma
Hepatic Resection
TACE
Solitary Huge Tumor
Overall Survival
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-year overall survival
timeFrame: 3 years
Secondary outcomes:
measure: 1-year overall survival
timeFrame: 1 years
measure: 2-year overall survival
timeFrame: 2 years
measure: Recurrence rates
timeFrame: 3 years
Other outcomes:
measure: mortality
timeFrame: 30 days
Locations:
city: Wuhan
country: China
facility: Hepatic surgery center, Tong ji Hospital
state: Hubei
Study officials:
References:
citation: Yin L, Li H, Li AJ, Lau WY, Pan ZY, Lai EC, Wu MC, Zhou WP. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan Criteria: a RCT. J Hepatol. 2014 Jul;61(1):82-8. doi: 10.1016/j.jhep.2014.03.012. Epub 2014 Mar 17.
citation: Metussin A, Patanwala I, Cross TJ. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan criteria: a RCT. J Hepatol. 2015 Mar;62(3):747-8. doi: 10.1016/j.jhep.2014.08.057. Epub 2014 Nov 7. No abstract available.
citation: Jin YJ, Lee JW, Choi YJ, Chung HJ, Kim YS, Lee KY, Ahn SI, Shin WY, Cho SG, Jeon YS. Surgery versus transarterial chemoembolization for solitary large hepatocellular carcinoma of BCLC stage A. J Gastrointest Surg. 2014 Mar;18(3):555-61. doi: 10.1007/s11605-013-2440-x. Epub 2014 Jan 14.