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

February 9, 2020 updated by: Chen Min-Shan, Sun Yat-sen University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib
Sorafenib (Nexavar) 200mg tablet, 2 tablets oral daily for 2 years, starting within 4weeks after hepatectomy. Regular treatment combined.
Drug: Sorafenib
red round tablet
Other Names:
  • Nexavar
No Intervention: Control
No use of Sorafenib (Nexavar). Regular treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: 2 years
To determine the recurrence free survival rate at 2 years after hepatectomy
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Minshan Chen, PHD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

July 10, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 9, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sorafenib-MVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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