Adjuvant Therapies for Patients With HCC and MVI

Hepatocellular Carcinoma Clinical Trial

— A-TACE/S-HCC  

Official title:

Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436902
• Other study ID #: A-TACE/S-HCC
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: January 2020
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis.

Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 30, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

• Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients

• Patients with microvascular invasion by histopathological examination of surgical samples

• Patients have Child-Pugh A or B liver function

• No previous neoadjuvant treatment

• No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings

• No malignancy other than HCC for 5 years prior to the initial HCC treatment

Exclusion Criteria:

• History of cardiac disease

• Known history of human immunodeficiency virus (HIV) infection

• Known Central Nervous System tumors including metastatic brain disease

• History of organ allograft

• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

• Pregnant or breast-feeding patients

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• TACE
TACE is performed one month after resection.

Drug:
• Sorafenib
Sorafenib is submitted one month after resection.
• TACE plus sorafenib
TACE plus sorafenib will be submitted one month after resection.

Other:
• empty control
This group will not receive adjuvant therapy.

Locations

Country	Name	City	State
China	Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857. — View Citation

Zhong JH, Li LQ. Postoperative adjuvant transarterial chemoembolization for participants with hepatocellular carcinoma: A meta-analysis. Hepatol Res. 2010 Oct;40(10):943-53. doi: 10.1111/j.1872-034X.2010.00710.x. — View Citation

Zhou L, Rui JA, Wang SB, Chen SG, Qu Q. Early recurrence in large hepatocellular carcinoma after curative hepatic resection: prognostic significance and risk factors. Hepatogastroenterology. 2014 Oct;61(135):2035-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survivals		1 year
Secondary	Hospital mortality		30-day
Secondary	Recurrence rates		1 years