NCT02867280

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

July 10, 2016

Last Update Submit

February 9, 2020

Conditions

Hepatocellular CarcinomaRecurrence

Keywords

SorafenibMicrovascular invasionadjuvant therapyhepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival

    To determine the recurrence free survival rate at 2 years after hepatectomy

    2 years

Secondary Outcomes (6)

  • Time To Recurrence

    From date of liver resection until the date of first documented relapse, assessed up to 5 years

  • Recurrence rate

    2 years

  • Recurrence free survival

    1year, 3years, 5 years

  • Overall survival

    3 years, 5 years

  • Incidence of Treatment-related Adverse Events measures using CTCAE v4.0

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Sorafenib

EXPERIMENTAL

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

Drug: Sorafenib

Control

NO INTERVENTION

No use of Sorafenib (Nexavar). Regular treatment.

Interventions

SorafenibDRUG

red round tablet

Also known as: Nexavar
Sorafenib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • Hepatocellular carcinoma confirmed by pathology
  • No macroscopic tumor thrombus vascular invasion and distant metastasis
  • R0 resection（clean resection margin both macroscopically and microscopically）
  • MVI confirmed by pathology
  • ECOG 0-1
  • Child-Pugh stage A
  • WBC \> 3×10E9/L；HB \> 90 G/L；PLT \> 50×10E9/L
  • 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

You may not qualify if:

  • Tumor rupture or invading to adjacent organs
  • Patients who underwent liver transplantation
  • Past history of or simultaneously receiving other anti-cancer therapy (such as TACE, chemotherapy, radiotherapy and others）and immune cell infusion therapy
  • Uncontrolled cardiovascular and cerebrovascular diseases
  • History of gastrointestinal bleeding within 6 months
  • Active infection other than HBV, HCV
  • Postoperative complications, not suitable to take Sorafenib (such as long term use of drainage due to bile leakage, poor wound healing and others)
  • Confirmed liver cancer recurrence or metastasis within 4 weeks after hepatectomy
  • Poor compliance, cannot adhere to regular follow up
  • Diagnosed with other original malignant tumors other than HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Minshan Chen, PHD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Hepatobiliary Surgery

Study Record Dates

First Submitted

July 10, 2016

First Posted

August 15, 2016

Study Start

June 1, 2016

Primary Completion

August 31, 2019

Study Completion

January 31, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)