NCT02436902

Adjuvant Therapies for Patients With HCC and MVI

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	TACE	TACE is performed one month after resection.
DRUG	Sorafenib	Sorafenib is submitted one month after resection.
DRUG	TACE plus sorafenib	TACE plus sorafenib will be submitted one month after resection.
OTHER	empty control	This group will not receive adjuvant therapy.

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-08-23
• Completion: 2022-08-30
• First posted: 2015-05-07
• Last updated: 2020-01-10

Locations

1 site across 1 country: China