Adjuvant Therapies for Patients With HCC and MVI (A-TACE/S-HCC)

Guangxi Medical University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Other: empty control; Drug: Sorafenib; Drug: TACE plus sorafenib; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT02436902

A-TACE/S-HCC

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

TACE

Experimental group

Description:

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

Treatment:

Procedure: TACE

Other: empty control

sorafenib

Active Comparator group

Description:

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

Treatment:

Drug: Sorafenib

TACE plus sorafenib

Other group

Description:

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.

Treatment:

Drug: TACE plus sorafenib

Other: empty control

empty control

No Intervention group

Description:

This group patients will receive best supportive care.