Sorafenib Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection

Sun Yat-sen University

Status and phase

Terminated

Phase 3

Conditions

Hepatocellular Carcinoma

Recurrence

Treatments

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT02867280

Sorafenib-MVI

Details and patient eligibility

About

This prospective multicenter non-randomized controlled study evaluates the efficacy and safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with microvascular invasion after radical resection compared to conventional therapies.

Full description

The study is a multicenter, non-randomized, open-label, blank controlled study which initiated by Investigators. The study population include patients without macroscopic vascular invasion and distant metastasis, undergoing R0 resection, postoperative pathology confirming hepatocellular carcinoma with microvascular invasion (MVI) (BCLC A or B stage; T2 or part T3aN0M0). The primary end point of this study is recurrence free survival（RFS）at the 2nd postoperative years, and the secondary end points include postoperative median time to recurrence (TTR), 1-year, 3-years, 5-years postoperative recurrence free survival (RFS), 3-years, 5-years postoperative overall survival, and safety and tolerance of sorafenib as an adjuvant therapy for HCC. Patients in the treatment group will start Sorafenib within 4 weeks after hepatectomy at doze of 400mg per day, and last continuously for 2 years, or until disease progression. Patients in the control group will take regular treatment with no use of Sorafenib. Both groups are forbid receiving postoperative anti-cancer therapy such as adjuvant radiotherapy, chemotherapy and TACE. Patients of both groups should receive antiviral therapy according to guidelines. Chinese traditional medicine and nutritional support can be used without limitation, and the information of concomitant drug need to be recorded for further analysis. Treatment for relieve drug related AEs can be used as needed. Patients of both groups will be treated with best clinical practice as routine after confirmed recurrence/metastasis, and the information of further treatment need to be recorded and follow-up till death.

Enrollment

154 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-75 years
Hepatocellular carcinoma confirmed by pathology
No macroscopic tumor thrombus vascular invasion and distant metastasis
R0 resection（clean resection margin both macroscopically and microscopically）
MVI confirmed by pathology
ECOG 0-1
Child-Pugh stage A
WBC > 3×10E9/L；HB > 90 G/L；PLT > 50×10E9/L
ALT，AST not exceeding 5 times of the upper limit of normal value；CRE，TBIL not exceeding 1.5 times of the upper limit of normal value

Exclusion criteria

Tumor rupture or invading to adjacent organs
Patients who underwent liver transplantation
Past history of or simultaneously receiving other anti-cancer therapy (such as TACE, chemotherapy, radiotherapy and others）and immune cell infusion therapy
Uncontrolled cardiovascular and cerebrovascular diseases
History of gastrointestinal bleeding within 6 months
Active infection other than HBV, HCV
Postoperative complications, not suitable to take Sorafenib (such as long term use of drainage due to bile leakage, poor wound healing and others)
Confirmed liver cancer recurrence or metastasis within 4 weeks after hepatectomy
Poor compliance, cannot adhere to regular follow up
Diagnosed with other original malignant tumors other than HCC