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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Prospective Multicenter Non-randomized Controlled Study of Sorafenib (Nexavar) Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02867280
• Other study ID #: Sorafenib-MVI
• Status: Terminated
• Phase: Phase 3
• Start date: June 1, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: January 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Drug:
• Sorafenib
red round tablet

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival	To determine the recurrence free survival rate at 2 years after hepatectomy	2 years
Secondary	Time To Recurrence	To determine the median postoperative time to recurrence	From date of liver resection until the date of first documented relapse, assessed up to 5 years
Secondary	Recurrence rate	To determine the recurrence rate within 2 years after hepatectomy	2 years
Secondary	Recurrence free survival	To determine the recurrence free survival at postoperative 1-year, 3-year, and 5-year	1year, 3years, 5 years
Secondary	Overall survival	To determine the overall survival at postoperative 3-year and 5-year	3 years, 5 years
Secondary	Incidence of Treatment-related Adverse Events measures using CTCAE v4.0	measures using CTCAE v4.0	2 years
Secondary	Incidence of dose modification of sorafenib due to adverse events.	The actual total dose of sorafenib for every patients will be collected as well.	2 years