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

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ClinicalTrials.gov Identifier: NCT02867280
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Chen Min-Shan, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Recurrence Drug: Sorafenib Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Non-randomized Controlled Study of Sorafenib (Nexavar) Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection
Study Start Date : June 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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 Name: Nexavar

No Intervention: Control
No use of Sorafenib (Nexavar). Regular treatment.



Primary Outcome Measures :
  1. Recurrence free survival [ Time Frame: 2 years ]
    To determine the recurrence free survival rate at 2 years after hepatectomy


Secondary Outcome Measures :
  1. 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

  2. Recurrence rate [ Time Frame: 2 years ]
    To determine the recurrence rate within 2 years after hepatectomy

  3. Recurrence free survival [ Time Frame: 1year, 3years, 5 years ]
    To determine the recurrence free survival at postoperative 1-year, 3-year, and 5-year

  4. Overall survival [ Time Frame: 3 years, 5 years ]
    To determine the overall survival at postoperative 3-year and 5-year

  5. Incidence of Treatment-related Adverse Events measures using CTCAE v4.0 [ Time Frame: 2 years ]
    measures using CTCAE v4.0

  6. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867280


Contacts
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Contact: Minshan Chen, M.D 020-87343117 chenmsh@sysucc.org.cn
Contact: Li Xu, M.D xuli@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Minshan Cchen, M.D.    8620-87343117    chenmsh@sysucc.org.cn   
Contact: Li Xu, M.D.       xuli@sysucc.org.cn   
Principal Investigator: Minshan Chen, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Minshan Chen, PHD Sun Yat-sen University

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Responsible Party: Chen Min-Shan, Director of the Department of Hepatobiliary Surgery, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02867280     History of Changes
Other Study ID Numbers: Sorafenib-MVI
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chen Min-Shan, Sun Yat-sen University:
Sorafenib
Microvascular invasion
adjuvant therapy
hepatocellular carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action