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

NCT ID: NCT02867280

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2020-01-31

Brief 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.

Detailed 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.

Conditions

Hepatocellular Carcinoma; Recurrence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sorafenib

Sorafenib (Nexavar) 200mg tablet, 2 tablets oral daily for 2 years, starting within 4weeks after hepatectomy. Regular treatment combined.

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

red round tablet

Control

No use of Sorafenib (Nexavar). Regular treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sorafenib

red round tablet

Intervention Type: DRUG

Other Intervention Names

Nexavar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Chen Min-Shan

Director of the Department of Hepatobiliary Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minshan Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Sorafenib-MVI

Identifier Type: -

Identifier Source: org_study_id