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

• Status: Terminated
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

1. Age 18-75 years

2. Hepatocellular carcinoma confirmed by pathology

3. No macroscopic tumor thrombus vascular invasion and distant metastasis

4. R0 resection（clean resection margin both macroscopically and microscopically）

5. MVI confirmed by pathology

6. ECOG 0-1

7. Child-Pugh stage A

8. WBC > 3×10E9/L；HB > 90 G/L；PLT > 50×10E9/L

9. 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:

1. Tumor rupture or invading to adjacent organs

2. Patients who underwent liver transplantation

3. Past history of or simultaneously receiving other anti-cancer therapy (such as TACE, chemotherapy, radiotherapy and others）and immune cell infusion therapy

4. Uncontrolled cardiovascular and cerebrovascular diseases

5. History of gastrointestinal bleeding within 6 months

6. Active infection other than HBV, HCV

7. Postoperative complications, not suitable to take Sorafenib (such as long term use of drainage due to bile leakage, poor wound healing and others)

8. Confirmed liver cancer recurrence or metastasis within 4 weeks after hepatectomy

9. Poor compliance, cannot adhere to regular follow up

10. Diagnosed with other original malignant tumors other than HCC