Adjuvant Therapies for Patients With HCC and MVI

NCT02436902 | Unknown Phase 3

• 1 other identifier: A-TACE/S-HCC
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survivals

  1 year

Secondary Outcomes (2)

• Hospital mortality

  30-day

• Recurrence rates

  1 years

Study Arms (4)

TACE

EXPERIMENTAL

Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.

Procedure: TACE; Other: empty control

sorafenib

ACTIVE COMPARATOR

Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.

Drug: Sorafenib

TACE plus sorafenib

OTHER

Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection. At the same time, TACE is performed two to four weeks after hepatic resection.

Drug: TACE plus sorafenib; Other: empty control

empty control

NO INTERVENTION

This group patients will receive best supportive care.

Interventions

TACE PROCEDURE

TACE is performed one month after resection.

Also known as: transarterial chemoembolization

TACE

Sorafenib DRUG

Sorafenib is submitted one month after resection.

sorafenib

TACE plus sorafenib DRUG

TACE plus sorafenib will be submitted one month after resection.

TACE plus sorafenib

empty control OTHER

This group will not receive adjuvant therapy.

TACE; TACE plus sorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, 530021, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 20887328 BACKGROUND

• 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, Haussinger 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.

  PMID: 18650514 BACKGROUND

• 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.

  PMID: 25713907 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangxi Medical University

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 7, 2015
• Study Start: February 1, 2019
• Primary Completion: August 23, 2022
• Study Completion: August 30, 2022
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

CN (1)